[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Radiation Therapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":634},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,117,0,25,[9,41,69,92,118,140,162,184,209,238,259,297,319,345,364,387,412,435,457,477,504,527,551,573,603],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100628797","phase-3-a-study-comparing-higher-dose-chemotherapy-over-a-shorter-amount-of-time-to-lower-dose-chemotherapy-plus-maintenance-over-a-longer-amount-of-time-in-patients-with-newly-diagnosed-intermediate-risk-rhabdomyosarcoma-ir-rms-100628797",false,"NCT07466316","A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)","A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC\u002FVI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma","Inclusion Criteria:\n\n* Patient must be ≤ 50 years of age at the time of enrollment\n* Patients with newly diagnosed soft tissue RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon FOXO1 fusion status, Stage, Intergroup Rhabdomyosarcoma Study (IRS) group, and age, as below. FOXO1 fusion status must be determined prior to enrollment. RMS types included under embryonal rhabdomyosarcoma (ERMS) include those which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (typical, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar Rhabdomyosarcoma (ARMS) in the 2020 WHO Classification is the same as in the International Classification of Rhabdomyosarcoma (ICR) and includes classic and solid variants.\n\n  * FOXO1 fusion negative (FN)\n\n    * Stage 2\u002F3, Group III\n    * Stage 4, Group IV, \\\u003C 10 years old\n  * FOXO1 fusion positive (FP)\n\n    * Stages 1-3, Groups I-III\n  * Disease\u002Fstaging imaging studies, if applicable, must be obtained within 21 days prior to enrollment and start of protocol therapy (repeat if necessary)\n* FOXO1 status results must be available to enroll. All patients will undergo institutional pathology review and institutional FOXO1 fusion determination regardless of histology prior to enrollment. FOXO1 status may confirmed by cytogenetic, fluorescence in situ hybridization (FISH), or next generation sequencing techniques. FOXO1 fusion results should be SUBMITTED as an upload to RAVE at study enrollment because this information is required for randomization.\n\nPlease note the following:\n\n* Institutional PAX3 versus (vs.) PAX7 determination is not required but should be submitted if available. Institutional FOXO1 testing may be performed at a contract or commercial lab as long as reports can be submitted and uploaded to RAVE. Additional molecular pathology reports, including the MCI report, are not required but should be submitted if available.\n* Patients who are \\\u003C 10 years old with distant metastatic disease (Stage 4) who have institutional molecular testing indicating fusion negative (FN) RMS but are later found to have fusion positive (FP) RMS by MCI or other testing will be considered to have metastatic FP disease and will go off study\n\n  * Appropriate lymph node sampling based on primary site of disease is required\n  * Patients must have a performance status of Lansky performance status score ≥ 50 for patients ≤ 16 years of age or Karnofsky performance status score ≥ 50 for patients \\> 16 years of age\n  * Peripheral absolute neutrophil count (ANC) ≥ 750\u002FμL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n  * Platelet count ≥ 75,000\u002FμL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n  * For pediatric patients \\\u003C 18 years of age:\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Maximum serum creatinine 0.4 mg\u002FdL (male), 0.4 mg\u002FdL (female)\n  * 6 months to \\\u003C 1 year: Maximum serum creatinine 0.5 mg\u002FdL (male), 0.5 mg\u002FdL (female)\n  * 1 to \\\u003C 2 years: Maximum serum creatinine 0.6 mg\u002FdL (male), 0.6 mg\u002FdL (female)\n  * 2 to \\\u003C 6 years: Maximum serum creatinine 0.8 mg\u002FdL (male), 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years: Maximum serum creatinine 1 mg\u002FdL (male), 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years: Maximum serum creatinine 1.2 mg\u002FdL (male), 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years: Maximum serum creatinine 1.5 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n  * ≥ 16 years: Maximum serum creatinine 1.7 mg\u002FdL (male),1.4 mg\u002FdL (female)\n* OR a 24-hour urine Creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n* OR a glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).\n\n  * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.\n* Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible. However, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (ie, percutaneous nephrostomies or ureteric stents) of the urinary tract.\n\nFor adult patients (aged 18 years or older):\n\n* Creatinine clearance ≥ 50 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or as a 24-hour urine collection. Estimated creatinine clearance is based on actual body weight.\n\n(All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n  * If there is evidence of biliary obstruction by tumor, then total bilirubin must be \\\u003C 3 x ULN for age\n* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Patients with evidence of uncontrolled infection are not eligible\n* Previous or concurrent cancer(s) that is\u002Fwas being treated with chemotherapy and\u002For radiation.\n\n  * Note: Surgical resection alone of previous or concurrent cancer(s) is allowed\n* Patients with central nervous system involvement of RMS as defined below:\n\n  * Malignant cells detected in cerebrospinal fluid\n  * Intra-parenchymal brain metastases separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed)\n  * Diffuse leptomeningeal disease\n* Patients with known Charcot-Marie-Tooth disease\n* Patients who have received any chemotherapy (excluding steroids) and\u002For radiation therapy for RMS prior to enrollment. Note: the following exception:\n\n  * Patients requiring emergency radiation therapy for life-threatening complications of tumor burden due to RMS. These patients are eligible, provided they are consented to ARST2531 prior to administration of radiation.\n  * Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (eg, autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","ALL","50 Years",{"count":20,"type":21},342,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.",[27],"Rhabdomyosarcoma","RECRUITING","2026-08-19",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2026-07-14",{"date":36,"type":21},"2031-03-31",{"name":38,"class":39},"Children's Oncology Group","NETWORK",85,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100614578","phase-2-testing-the-addition-of-cemiplimab-regn2810-to-chemotherapy-treatment-given-prior-to-surgery-in-patients-with-sinonasal-squamous-cell-carcinoma-100614578","NCT07281417","Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma","Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study","Inclusion Criteria:\n\n* Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin\n* Patients must have a T stage (T3, T4a, and select T4b) primary tumor according to American Joint Committee on Cancer (AJCC) 8th edition. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* No evidence of metastatic disease determined by pre-treatment imaging. Metastatic disease to neck nodes is considered locally advanced and therefore allowable. Patients with N0 and N1-3 disease will be eligible\n* Known HPV status (i.e., HPV negative, p16 immunohistochemistry \\[IHC\\] positive, high risk \\[HR\\]-HPV in situ hybridization \\[ISH\\] positive) from testing performed prior to referral. HPV status data (e.g., date of test, type of test \\[p16 IHC or HR-HPV ISH\\] and testing result) must be collected during enrollment. Patients who do not have this information available for collection will not be enrolled on this study\n* Age ≥ 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of cemiplimab (REGN2810) in combination with carboplatin and paclitaxel in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin ≥ 8 g\u002FdL (acceptable to reach via transfusion)\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine clearance ≥ 40 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. For this reason and because paclitaxel is a class D agent with the potential for teratogenic or abortifacient effects, women of childbearing potential (WCBP) and men should use highly effective contraception during treatment and for 6 months after the last dose of the study drugs. WCBP and men should avoid donating eggs\u002Fsperm during treatment and for 6 months after the last dose of the study drugs. Women should discontinue nursing during treatment and for 6 months after the last dose of the study drugs\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Prior to enrollment, verification of payment coverage by insurance (or other payment) for neoadjuvant paclitaxel and carboplatin chemotherapy must be obtained\n\nExclusion Criteria:\n\n* Patients with unresectable disease\n* Patients presenting with T3 disease without the need for maxillectomy and\u002For orbital invasion requiring orbital dissection\u002Fresection\n* Patients who have had any previous systemic therapy to the index lesion in the past 12 months. This includes cemiplimab (REGN2810) and\u002For other immune modulating agents. Previous systemic therapy may alter or affect response\n* Patients who had palliative RT (\\\u003C 20 Gy) within 1 week prior to entering the study\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)\n* History of pneumonitis within the last 5 years\n* Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab (REGN2810) or carboplatin and paclitaxel\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Men and WCBP who are not prepared to use highly effective contraception during and for 6 months after completion of treatment are excluded from this study","18 Years",{"count":50,"type":21},108,[52],"PHASE2","This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.",[55,56,57,58],"Sinonasal Squamous Cell Carcinoma","Stage III Sinonasal Cancer AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Sinonasal Cancer AJCC v8",{"date":60,"type":32},"2026-08-20",{"date":62,"type":21},"2026-11-24",{"date":64,"type":21},"2030-12-16",{"name":66,"class":67},"National Cancer Institute (NCI)","NIH",12,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100521017","phase-2-a-study-using-nivolumab-in-combination-with-chemotherapy-drugs-to-treat-nasopharyngeal-carcinoma-npc-100521017","NCT06064097","A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)","A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)","Inclusion Criteria:\n\n* Patients must be ≤ 21 years of age at the time of study enrollment\n* Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC)\n\n  * Patients must have had histologic verification of the malignancy at original diagnosis\n  * Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended\n* Patients must have had histologic verification of the malignancy at original diagnosis\n* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended\n* Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of ≥ 60%\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FuL (within 7 days prior to start of protocol therapy)\n* Platelet count ≥ 100,000\u002FuL (transfusion independent) (within 7 days prior to start of protocol therapy)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 or (within 7 days prior to start of protocol therapy)\n* A serum creatinine based on age\u002Fsex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg\u002FdL)\n\n  1 month to \\\u003C 6 months: 0.4 mg\u002FdL (male); 0.4 mg\u002FdL (female) 6 months to \\\u003C 1 year: 0.5 mg\u002FdL (male); 0.5 mg\u002FdL (female)\n\n  1 to \\\u003C 2 years: 0.6 mg\u002FdL (male); 0.6 mg\u002FdL (female) 2 to \\\u003C 6 years: 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female) 6 to \\\u003C 10 years 1 mg\u002FdL (male); 1 mg\u002FdL (female) 10 to \\\u003C13 years: 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female) 13 to \\\u003C 16 years: 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n\n  ≥ 16 years: 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy)\n* Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL\\* (within 7 days prior to start of protocol therapy)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Shortening fraction of ≥ 27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\nExclusion Criteria:\n\n* Patients who received prior radiotherapy to the head or neck\n* Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission\n* Patients with a diagnosis of immunodeficiency\n* Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n\n  * Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 0.25 mg\u002Fkg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 0.25 mg\u002Fkg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis\n* Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time\n* Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer\n* Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","21 Years",{"count":78,"type":21},50,[52],"This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and\u002For bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.",[82,83,84],"Stage II Nasopharyngeal Carcinoma AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8",{"date":60,"type":32},{"date":87,"type":32},"2024-06-25",{"date":89,"type":21},"2027-03-31",{"name":66,"class":67},86,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100652921","phase-2-a-multicenter-prospective-phase-ii-study-of-trop-2-adc-in-combination-with-toripalimab-for-resectable-locally-advanced-oral-squamous-cell-carcinoma-100652921","NCT07778368","A Multicenter, Prospective, Phase II Study of TROP-2 ADC in Combination With Toripalimab for Resectable Locally Advanced Oral Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Ages 18-75 (inclusive); no gender restrictions.\n2. Histologically or cytologically confirmed locally advanced oral squamous cell carcinoma (AJCC 8th Edition stages III-IVA).\n3. Resectable and having not previously received any antitumor therapy for oral squamous cell carcinoma.\n4. At least one evaluable tumor lesion according to RECIST version 1.1.\n5. A tumor tissue specimen must be provided or a tumor biopsy must be performed prior to receiving neoadjuvant therapy for Trop-2 and PD-L1 immunohistochemical testing.\n6. ECOG performance status of 0-1.\n7. Expected survival of 6 months or longer.\n8. Good bone marrow and organ function:\n\n   * Hematologic system (no blood transfusion or hematopoietic growth factor therapy within the past 14 days):\n\n     (1) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (2) Platelets (PLT) ≥ 100 × 10⁹\u002FL (3) Hemoglobin (Hb) ≥ 9 g\u002FL\n   * Liver function\n\n     (1) Total bilirubin (TBIL) ≤ 1.5 × ULN (2) Alanine aminotransferase (ALT) ≤ 3 × ULN (3) Aspartate aminotransferase (AST) ≤ 3×ULN\n   * Renal function\n\n     1. Creatinine (Cr) ≤ 1.5×ULN\n     2. Creatinine clearance (Ccr) (to be calculated only when creatinine \\> 1.5×ULN) \\> 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Coagulation function (applicable to patients not receiving anticoagulant therapy; for subjects receiving anticoagulant therapy, INR or APTT should be within the expected therapeutic range for the anticoagulant)\n\n     1. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN\n     2. International Normalized Ratio (INR) ≤ 1.5×ULN\n9. Eligible patients of reproductive potential (both men and women) must agree to use reliable contraception (such as hormonal, barrier, or abstinence methods) with their partners during the trial and for at least 6 months after the last dose of treatment; female patients of childbearing potential (as defined in Appendix 5) must have a negative blood or urine pregnancy test within 7 days prior to the first administration of the study drug.\n10. Subjects must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Presence of precancerous lesions such as oral leukoplakia, erythroplakia, or lichen planus.\n2. History of head and neck radiation therapy.\n3. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.\n4. Received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration of the study drug.\n5. Underwent major organ surgery (excluding needle biopsies and tracheotomies) or sustained significant trauma within 4 weeks prior to the first administration of the study drug.\n6. Received an attenuated live vaccine within 4 weeks prior to the first administration of the study drug.\n7. Patients who have received, within 14 days prior to the first administration of the study drug, or who require long-term systemic administration of glucocorticoids (prednisone \\> 10 mg\u002Fday or an equivalent dose of a similar drug) or other immunosuppressants during the study; the following exceptions apply: treatment with topical, ophthalmic, intra-articular, intranasal, or inhaled glucocorticoids; and short-term use of glucocorticoids for prophylactic treatment (e.g., to prevent contrast medium allergy).\n8. Patients with active autoimmune diseases or a history of such diseases with a risk of recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid disease or type 1 diabetes.\n9. A history of other malignancies within 5 years prior to the first administration of the study drug, excluding tumors with negligible risk of metastasis or death, such as cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ of the breast.\n10. A history of immunodeficiency, including a positive HIV antibody test.\n11. Active infection currently requiring intravenous antimicrobial therapy.\n12. Active hepatitis B (HBsAg-positive and HBV-DNA \\> 500 IU\u002FmL or the study site's lower limit of detection \\[only if the study site's lower limit of detection is higher than 500 IU\u002FmL\\]), active hepatitis C (patients who are HCV-antibody-positive but have HCV-RNA \\\u003C the study site's lower limit of detection are eligible for inclusion); patients receiving prophylactic antiviral therapy other than interferon are eligible for inclusion. For subjects who are HBsAg-positive but HBV-DNA-negative, prophylactic antiviral therapy other than interferon must be administered.\n13. Patients currently suffering from interstitial lung disease (excluding radiation-induced pulmonary fibrosis not requiring steroid therapy) or from pulmonary comorbidities resulting in clinically significant pulmonary dysfunction.\n14. Patients currently suffering from active inflammatory bowel disease (ulcerative colitis, Crohn's disease).\n15. Patients with a history of severe cardiovascular or cerebrovascular disease, including but not limited to:\n\n(1) Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention or second- or third-degree atrioventricular block; (2) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular or cerebrovascular events of Grade 3 or higher occurring within 6 months prior to the first dose; (3) Heart failure classified as New York Heart Association (NYHA) Class II or higher, or a left ventricular ejection fraction (LVEF) \\\u003C 50%, or other structural heart disease deemed high-risk by the investigator; (4) Clinically uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 95 mmHg despite treatment).\n\n16\\. Known history of severe allergic reactions to macromolecular drugs. 17. Known alcohol or drug dependence. 18. Patients with psychiatric disorders or poor compliance. 19. Pregnant or breastfeeding women. 20. Patients with a history of other serious systemic diseases, or other reasons deemed by the investigator to make them unsuitable for participation in this clinical trial.","75 Years",{"count":100,"type":21},20,[52],"This study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or chemoradiotherapy.",[104],"Oral Squamous Cell Carcinoma (OSCC)",[106],"Oral Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-08-18",{"date":31,"type":32},{"date":111,"type":21},"2026-09-01",{"date":113,"type":21},"2029-08-31",{"name":115,"class":116},"Shanghai East Hospital","OTHER",1,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100578871","phase-2-trial-of-glioblastoma-immunotherapy-advancement-with-nivolumab-and-relatlimab-100578871","NCT06816927","Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab","A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab (GIANT)","GIANT","Inclusion Criteria:\n\n1. Signed informed consent approved by the IRB\n2. Adults ≥ 18 years of age\n3. Patients with either:\n\n   * A newly suspected diagnosis of GBM based on MRI\n   * A previous diagnosis of GBM and who have not received prior RT or systemic therapy for their brain tumor\n4. Patients who in the opinion of the treating neurosurgeon require resection\n5. Patient is willing to undergo planned surgical procedures\n6. Patient agrees to make biospecimens that will be prospectively collected (after date of consent) available for research\n7. Patients who have undergone a diagnostic biopsy or open surgical procedure prior to enrolling in this study:\n\n   * If adequate archival tissue, defined as at least 3 blocks, is readily available, there is clear documentation of its availability, and the patient must consents to provide that tissue, the patient does not need to undergo another biopsy prior to, or on study, in order to be eligible for this trial\n   * If archival tissue is sufficient as described above, patient must have either residual enhancing disease requiring resection, or molecularly confirmed GBM with a clear clinical indication for additional resection, as determined by the country PI (or delegate) and the designated trial surgeon.\n   * If archival tissue is insufficient, or if the patient previously underwent a needle biopsy and there is no clear documentation of tissue availability, and the patient wishes to enroll, the patient must agree to undergo a repeat biopsy as part of this study prior to Screening.\n8. Hematological function as follows:\n\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Haemoglobin \\> 90 g\u002FL\n   * Prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.5 x upper limit of normal (ULN)\n9. Renal function as follows:\n\n   • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 ml\u002Fmin using the Cockcroft-Gault formula (Appendix 1)\n10. Hepatic function as follows:\n\n    * Total bilirubin ≤ 1.5 x ULN (Exception: Patient has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable)\n    * Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n    * Serum albumin ≥ 25 g\u002FL\n11. Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 (Appendix 2)\n12. Life expectancy of at least 12 months\n13. Negative human immunodeficiency virus (HIV) test at Screening\n14. Negative hepatitis B surface antigen (HbsAg) test at Screening or positive test followed by a negative hepatitis B virus (HBV) DNA test at Screening\n15. Negative hepatitis C antibody (anti-HCV) test at Screening or positive test followed by a negative HCV RNA test at Screening\n16. Able to undergo brain MRI with and without contrast\n17. People of childbearing potential must agree to use a highly effective contraceptive method (with a failure rate of \\\u003C 1%) during study treatment and for at least 6 months following the last dose of study drug and agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Acceptable methods of contraception are:\n\n    * Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n    * Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n    * Intrauterine device: Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomised partner\n    * Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence needs will be evaluated in relation to the duration of the study and to the usual lifestyle of the patient Note: People are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the person has been confirmed by follow-up hormone level assessment are they considered not of childbearing potential.\n18. Sexually active patients that are able to produce a sperm, must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 3 months after the last dose of treatment\n19. People of childbearing potential must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) at the time of screening and within 48 hours of starting the study drug(s)\n20. Ability to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria:\n\n1. Tumors where a gross total resection is not considered feasible by the treating neurosurgeon\n2. Tumor involves cerebellum, brainstem, or deep basal ganglia\n3. Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon\n4. Patients with contraindications to MRI or unwilling to undergo MRI\n5. History of CNS bleeding as defined by stroke within 6 months prior to registration\n6. Contraindication to surgery\n7. Treatment with immunosuppressive medications Note: Low-dose corticosteroids (≤ 2 mg\u002Fday dexamethasone or equivalent) for tumor-associated edema is permitted. Patients who require corticosteroids \\> 2mg\u002Fday dexamethasone (or equivalent) for acute emergencies during the screening window will be eligible, if the corticosteroid dosing reduces to ≤ 2 mg\u002Fday dexamethasone (or equivalent) at least one day prior to the initial trial-mandated biopsy.\n8. Active autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis\n9. Active tuberculosis\n10. Patient has had a previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms must have resolved and based on treating physician's assessment, there are no sequelae that would place the patient at a higher risk of receiving trial treatment\n11. Evidence of acute intracranial\u002Fintra-tumoral hemorrhage, which requires urgent intervention\n12. Severe infection within 4 weeks prior to registration\n13. Treatment with a live, attenuated vaccine within 4 weeks prior to registration, or anticipation of need for such a vaccine during study or within 5 months after final dose of nivolumab and relatlimab\n14. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more\n15. Major surgical procedure, other than for diagnosis, within 4 weeks prior to registration\n16. History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n17. Patient is pregnant or breastfeeding\u002Fchestfeeding\n18. Prior allogeneic stem cell or solid organ transplantation\n19. Known allergy or sensitivity nivolumab, relatlimab, temozolomide or their excipients\n20. Patient has any kind of disorder that, in the opinion of the site PI, may compromise the ability of the patient to give written informed consent and\u002For to comply with all required study procedures\n21. Patients with a history of myocarditis\n22. Patient has troponin T (TnT) or I (TnI) \\> 2 × ULN Note: Patients with TnT or TnI levels between \\> 1 × to 2 × ULN will be eligible if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \\> 1 × to 2 × ULN within 24 hours, the patient must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the patient must be evaluated by a cardiologist. After cardiologist evaluation, the patient may be eligible if the site PI assesses a favorable benefit\u002Frisk\n23. Left ventricular ejection fraction (LVEF) \\\u003C 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 6 months prior to registration\n24. History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the site PI would pose a risk to patient safety or interfere with the study evaluation, procedures or completion",{"count":127,"type":21},92,[52],"GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).",[131],"Newly Diagnosed Glioblastoma",{"date":29,"type":32},{"date":134,"type":32},"2025-11-28",{"date":136,"type":21},"2031-06-01",{"name":138,"class":116},"Duke University",3,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100529324","dinutuximab-with-chemotherapy-surgery-and-stem-cell-transplantation-for-the-treatment-of-children-with-newly-diagnosed-high-risk-neuroblastoma-100529324","NCT06172296","Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131\n* ≤ 30 years at the time of initial diagnosis with high-risk disease\n* \\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines\n\n  * Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:\n\n    * Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification\n    * Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)\n    * Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy\n    * Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)\n* Patients must have a body surface area (BSA) ≥ 0.25 m\\^2\n* No prior anti-cancer therapy except as outlined below:\n\n  * Patients initially recognized to have high-risk disease treated with topotecan\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing, and with consent\n  * Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria\n  * Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis\n* Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Male 0.4 mg\u002FdL and female 0.4mg\u002FdL\n  * 6 months to \\\u003C 1 year: Male 0.5 mg\u002FdL and female 0.5 mg\u002FdL\n  * 1 to \\\u003C 2 years: Male 0.6 mg\u002FdL and female 0.6 mg\u002FdL\n  * 2 to \\\u003C 6 years: Male 0.8 mg\u002FdL and female 0.8 mg\u002FdL\n  * 6 to \\\u003C 10 years: Male 1 mg\u002FdL and female 1 mg\u002FdL\n  * 10 to \\\u003C 13 years: Male 1.2 mg\u002FdL and female 1.2 mg\u002FdL\n  * 13 to \\\u003C 16 years: Male 1.5 mg\u002FdL and female 1.4 mg\u002FdL\n  * ≥ 16 years: Male 1.7 mg\u002FdL and female 1.4 mg\u002FdL\n\n    * The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)\n  * or a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 or\n  * or a GFR ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n\n    * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \\[ALT\\]) ≤ 10 x ULN\\*\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* \\* Shortening fraction of ≥ 27% by echocardiogram, or\n\n  * Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n* Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:\n\nNo known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n\nExclusion Criteria:\n\n* Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features\n* Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features\n* Patients with known bone marrow failure syndromes\n* Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention\u002Ftreatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable\n* Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","30 Years",{"count":149,"type":21},478,[24],"This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.",[153,154],"Ganglioneuroblastoma, Nodular","Neuroblastoma",{"date":29,"type":32},{"date":157,"type":32},"2024-04-19",{"date":159,"type":21},"2029-12-31",{"name":66,"class":67},179,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":169,"maxAge":76,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},"100446866","phase-1-a-study-of-the-drug-selinexor-with-radiation-therapy-in-patients-with-newly-diagnosed-diffuse-intrinsic-pontine-dipg-glioma-and-high-grade-glioma-hgg-100446866","NCT05099003","A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)","A Phase 1\u002F2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)","Inclusion Criteria:\n\n* PRE ENROLLMENT: Patients must be =\\\u003C 25 years of age at the time of enrollment on APEC14B1 part A central nervous system (CNS)\u002Fhigh grade glioma (HGG) pre-enrollment eligibility screening\n\n  * Please note:\n\n    * This required age range applies to pre-enrollment eligibility for all HGG patients. Individual treatment protocols may have different age criteria.\n    * Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are \\>= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).\n* PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG\n\n  * Please note: there are specific radiographic criteria for DIPG patient enrollment on ACNS1821 (Step 1)\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n* PRE ENROLLMENT:\n\n  * For patients with non-pontine tumors: Patients and\u002For their parents or legal guardians must have signed informed consent for eligibility screening on APEC14B1 Part A.\n  * For patients with DIPG: Patients and\u002For their parents or legal guardians must have signed informed consent for ACNS1821.\n  * Note: As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n* PRE ENROLLMENT:\n\n  * For patients with non-pontine tumors only, the specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 ASAP, preferably within 5 calendar days of definitive surgery\n* STEP 1: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of enrollment\n* STEP 1: Patients must have newly-diagnosed DIPG or HGG (including DMG).\n* STEP 1: Stratum DIPG (Closed with Amendment #4)\n\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n  * Patients with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons on at least 1 axial T2 weighted image, are eligible. No histologic confirmation is required.\n  * Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2\u002F3 of the pontine cross-sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma not otherwise specified \\[NOS\\], and\u002For H3 K27M-mutant) by institutional diagnosis.\n* STEP 1: Stratum DMG (with H3 K27M mutation) (Closed with Amendment #4)\n\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n  * Patients must have newly-diagnosed non-pontine H3 K27M-mutant HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1\n  * Note: Patients need not have either measurable or evaluable disease, i.e., DMG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment. For rare H3 K27M-mutant HGG in non-midline structures (e.g., cerebral hemispheres), these patients will be considered part of Stratum DMG.\n* STEP 1: Stratum HGG (without H3 K27M mutation)\n\n  * Patients must have newly-diagnosed non-pontine H3 K27M-wild type HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1\n  * Please note:\n\n    * Patients who fall in this category and who are \\>= 18 years of age are not eligible due to another standard-of-care regimen (radiation\u002Ftemozolomide) that is available\n    * Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment\n* STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* STEP 1: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to step 1 enrollment)\n* STEP 1: Platelet count \\>= 100,000\u002FuL (transfusion independent) (within 7 days prior to step 1 enrollment)\n* STEP 1: Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to step 1 enrollment)\n* STEP 1: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to step 1 enrollment) or\n\nA serum creatinine based on age\u002Fsex as follows (within 7 days prior to step 1 enrollment):\n\n* Age \u002F Maximum Serum Creatinine (mg\u002FdL)\n\n  * 1 to \\\u003C 2 years \u002F male: 0.6; female: 0.6\n  * 2 to \\\u003C 6 years \u002F male: 0.8; female: 0.8\n  * 6 to \\\u003C 10 years \u002F male: 1; female: 1\n  * 10 to \\\u003C 13 years \u002F male: 1.2; female: 1.2\n  * 13 to \\\u003C 16 years \u002F male: 1.5; female: 1.4\n  * \\>= 16 years \u002F male: 1.7; female: 1.4\n\n    * STEP 1: Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age\n    * STEP 1: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n    * STEP 1: Serum amylase =\\\u003C 1.5 x ULN\n    * STEP 1: Serum lipase =\\\u003C 1.5 x ULN\n    * STEP 1: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination.\n    * STEP 1: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n    * STEP 1: Patients must be enrolled and protocol therapy must begin no later than 31 days after the date of radiographic diagnosis (in the case of non-biopsied DIPG patients only) or definitive surgery, whichever is the later date (Day 0).\n\nFor patients who have a biopsy followed by resection, the date of resection will be considered the date of definitive diagnostic surgery. If a biopsy only was performed, the biopsy date will be considered the date of definitive diagnostic surgery.\n\nExclusion Criteria:\n\n* STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications.\n* STEP 1: Patients who are currently receiving another investigational drug are not eligible.\n* STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.\n* STEP 1: Patients \\>=18 years of age who have H3 K27M-wild type HGG.\n* STEP 1: Patients who have an uncontrolled infection.\n* STEP 1: Patients who have received a prior solid organ transplantation.\n* STEP 1: Patients with grade \\> 1 extrapyramidal movement disorder.\n* STEP 1: Patients with known macular degeneration, uncontrolled glaucoma, or cataracts.\n* STEP 1: Patients with metastatic disease are not eligible; MRI of spine with and without contrast must be performed if metastatic disease is suspected by the treating physician.\n* STEP 1: Patients with gliomatosis cerebri type 1 or 2 are not eligible, with the exception of H3 K27M-mutant bithalamic tumors.\n* STEP 1: Patients who are not able to receive protocol specified radiation therapy.\n* STEP 1:\n\n  * Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.\n  * Lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk.\n  * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.\n  * Sexually active patients of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control (including a medically accepted barrier method of contraception, e.g., male or female condom) for the duration of their study participation and for 90 days after the last dose of selinexor. Abstinence is an acceptable method of birth control.","12 Months",{"count":171,"type":21},132,[173,52],"PHASE1","This phase I\u002FII trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.",[176],"Malignant Glioma",{"date":29,"type":32},{"date":179,"type":32},"2022-05-31",{"date":181,"type":21},"2027-06-30",{"name":66,"class":67},127,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":191,"minAge":48,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":139},"100406082","comparison-of-proton-or-intensity-modulated-radiation-therapy-after-surgery-for-endometrial-or-cervical-cancer-100406082","NCT04567771","Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer","A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of cervical or endometrial cancer\n* Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium\n* History and physical prior to registration\n* Documentation of history of:\n\n  * Smoking status\n  * Pelvic infection\n  * Pelvic inflammatory disease\n  * Endometriosis\n* Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site\n* Plan for RT to pelvis with or without para-aortic lymph node irradiation\n* If received high-dose chemotherapy prior to registration, last dose must have been given \\>= 21 days prior to start of RT\n* Complete blood count (CBC) performed within 21 days prior to registration\n* Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)\u002FCT, or PET\u002FMRI for staging before registration; may be pre-operative (op) or post-op\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-2\n* Provide written informed consent\n* Willing to complete quality of life (QOL) questionnaires\n\nExclusion Criteria:\n\n* Receiving external beam boost dose during RT\n* Distant metastases\n* Gross disease at time of RT\n* Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas\n* Patients who exceed the weight\u002Fsize limits of the treatment table\n* Positive or close surgical margins (=\\\u003C 3 mm)\n* Prior RT to the pelvis\n* Planned to receive inguinal node RT\n* Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n* Other major medical illness which requires hospitalization or precludes study therapy at the time of registration\n* Patients unwilling to have rectal balloon placed on a daily basis during RT","FEMALE",{"count":193,"type":21},121,[195],"NA","This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.",[198,199,200,201],"Cervical Carcinoma","Endometrial Carcinoma","Endometriosis","Pelvic Inflammatory Disease",{"date":29,"type":32},{"date":204,"type":32},"2020-12-04",{"date":206,"type":21},"2029-04-01",{"name":208,"class":116},"Mayo Clinic",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":216,"minAge":147,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":117},"100611183","phase-2-abipred--adt-vs-adt-in-psma-positive-conventionally-node-negative-prostate-cancer-100611183","NCT07237269","Abi\u002FPred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer","Abiraterone\u002FPrednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy","Inclusion Criteria:\n\n1. Histopathologically proven diagnosis of local prostate cancer. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.\n2. Targetable PSMA-avid pelvic lymph node measuring \\\u003C1cm in short axis diameter.\n3. No prior definitive treatment or intervention received.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days prior to registration.\n5. Age ≥ 30 years.\n6. Patient must be able to provide study-specific informed consent prior to study entry.\n7. Patient must be able to swallow medications.\n\nExclusion Criteria:\n\n1. Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).\n2. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.\n3. Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but are not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.\n4. Severe, active co-morbidity, defined as follows:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 3 months prior to registration.\n   2. Congestive heart failure (NYHA functional capacity class II or greater).\n   3. Transmural myocardial infarction within the last 3 months prior to registration.\n   4. History of stroke or transient ischemic attack within 3 months prior to registration.\n   5. Currently uncontrolled diabetes mellitus.\n   6. Ongoing arrhythmias of Grade \\>2 \\[National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE), version 5.03\\]; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.\n   7. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past month.\n   8. Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.\n   9. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n   10. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.\n   11. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n   12. Acquired Immune Deficiency Syndrome (AIDS) based upon the current Centers for Disease Control and Prevention definition that is being treated with contraindicated medications, including but not limited to Atazanavir, Saquinavir, Ritonavir, Indinavir, or Nelfinavir. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n   13. Uncontrolled seizures or seizures in the past 3 months. Patients can enroll if their seizures have been well-controlled for \\>3 months on antiseizure medications.\n   14. Gastrointestinal bleeding or any other hemorrhage\u002Fbleeding event CTCAE version 5 grade 3 or greater within 30 days prior to registration.\n   15. History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration.\n   16. Total bilirubin ≥1.5X upper limit of normal (ULN) \\[except for subjects with Gilbert's disease, in which case total bilirubin not to exceed 10X ULN\\], alanine (ALT) and aspartate (AST) aminotransferase \\>= 2.5X ULN.","MALE",{"count":218,"type":21},140,[52],"The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \\\u003C1 cm in smallest diameter).\n\nThis study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy.\n\nA total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes.\n\nThe primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival.\n\nExploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.",[222],"Prostate Cancer",[224,222,225,226,227,228,229],"PSMA-PET","Androgen Deprivation Therapy","Abiraterone","Radiation Therapy","Pelvic Lymphadenopathy","Hormone Therapy","2026-08-17",{"date":29,"type":32},{"date":233,"type":21},"2026-10-15",{"date":235,"type":21},"2033-04-03",{"name":237,"class":116},"University of Nebraska",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100582168","a-multi-center-observational-trial-of-symptomatic-high-risk-bone-metastases-treated-with-percutaneous-ablation-and-palliative-radiation-therapy-100582168","NCT06859801","A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy","TRIBUTE","Inclusion Criteria:\n\n* 1\\. Skeletal metastasis with localized pain not controlled medically \\[recall within last 24 hours of worst pain ≥ 5 using the BPI\\]\n* 2\\. Pain must be from one painful metastatic lesion involving the bone (additional less painful metastatic sites may be present). Extra-osseous extension of disease is allowed (must have some contact with the bone and be causing bone\u002Ftumor interface pain)\n* 3\\. Lesions that are at high-risk of skeletal related events defined as follows:\n* a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesions involving the spine\n* b. Pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional\u002Fmechanical pain\n* 4\\. Target lesion amenable to percutaneous ablation with image guidance AND RT by specialists' review\n* 5\\. No prior targeted radiation therapy or ablation to the index lesion\n* 6\\. ECOG performance status 0-2\n* 7\\. Age ≥ 21 years\n* 8\\. Have signed the current approved informed consent form\n* 9\\. Willing and able to answer follow-up Patient Reported Outcomes (PRO) surveys (e.g., PROMIS®, BPI, COST-FACIT, and OMED) for up to 12 months\n* 10\\. Life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* 1\\. Any medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.\n* 2\\. Target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \\> 50% loss of cortical bone \\[MIREL Score ≥ 7\\]\n* 3\\. Skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization\n* 4\\. Concurrent participation in other studies that could affect the primary endpoint\n* 5\\. Target tumor causing clinical or imaging evidence of spinal cord compression",{"count":246,"type":21},120,"OBSERVATIONAL","The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).",[250],"Bone Cancer Metastatic",{"date":29,"type":32},{"date":253,"type":32},"2025-10-23",{"date":255,"type":21},"2027-07-31",{"name":257,"class":116},"Society of Interventional Oncology",8,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100607990","phase-2-testing-the-addition-of-chemotherapy-or-chemo-immunotherapy-to-the-usual-surgery-for-advanced-head-and-neck-cancer-100607990","NCT07195734","Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer","A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent\u002FPersistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx\n* PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory\n* Verify insurance (or other payment) coverage for neoadjuvant chemotherapy\n* Measurable disease as defined by RECIST 1.1\n* Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer \\[AJCC\\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery:\n\n  * P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.\n  * Patients must be deemed surgically resectable without gross residual disease.\n  * For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.\n  * Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.\n  * Patients with resectable lymph node-only recurrence are eligible.\n  * No major vascular involvement (\\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection\n* No evidence of distant metastatic disease\n* The following minimum diagnostic workup is required:\n\n  * General history and physical examination.\n  * Diagnostic-quality neck CT and PET\u002FCT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002FdL (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8.0 g\u002FdL is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible.\n\n  * Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent\u002Frecurrent cancer volume (\\> 50%) irradiated to ≥ 40 Gy at the time\n* Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration\n* Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted\n* No investigational anti-cancer agents received within 4 weeks prior to registration\n* No New York Heart Association Functional Classification III or IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)\n* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments\n* No peripheral neuropathy grade 3 or 4\n* No history of interstitial lung disease\n* No active, noninfectious pneumonitis requiring immunosuppressive therapy\n* No history of a solid organ transplant (other than corneal transplant)\n* No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids \\[\\> 10 mg prednisone\u002Fday or equivalent\\] or immunosuppressive drugs)\n\n  * NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:\n\n    * Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded\n    * Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n    * Physiologic replacement doses ≤ 10 mg prednisone\u002Fday or equivalent are allowed. Inhaled or topical steroids are permitted\n* No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)",{"count":267,"type":21},180,[52],"This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.",[271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288],"Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma","Locally Recurrent Laryngeal Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","2026-08-15",{"date":108,"type":32},{"date":292,"type":32},"2026-04-24",{"date":294,"type":21},"2033-02-01",{"name":66,"class":67},106,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100575307","phase-2-testing-the-addition-of-the-immunotherapy-drug-pembrolizumab-to-radiation-therapy-compared-to-the-usual-chemotherapy-treatment-during-radiation-therapy-for-bladder-cancer-parrc-trial-100575307","NCT06770582","Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial","Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)","Inclusion Criteria:\n\n* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)\u002FCT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.\n\n  * NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible\n* High grade T1 disease history that must meet at least ONE of the three criteria below:\n\n  * Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+\u002F- focal carcinoma in situ \\[CIS\\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.\n  * T1 with pathologic high-risk features (lymphovascular invasion \\[LVI\\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)\n  * Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+\u002F- focal CIS) in the bladder. (No prior intravesical therapy required)\n* Restaging TURBT must be performed and must meet ALL of the following criteria below:\n\n  * If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.\n  * All grossly visible papillary tumors must be removed\n\n    * Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial\n* No pure squamous cell carcinoma or adenocarcinoma of the bladder\n* No neuroendocrine (small or large cell) features\n* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)\n* No prostatic urethral involvement\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 9 g\u002Fdl is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels \\> 1.5 × institutional ULN\n* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* All adverse events of their most recent therapy\u002Fintervention must have resolved to \\\u003C grade 3 or returned to baseline prior to registration\n* No history of pelvic radiation therapy\n* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed\n* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation\n* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \\[COVID\\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible\n* Patients must have recovered from acute cardiac illness\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection requiring IV antibiotics\n* No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis\n* No history of allogeneic bone marrow transplant or prior solid organ transplant\n* No active tuberculosis\n* No evidence of hydronephrosis\n* No history of upper tract urothelial carcinoma within 24 months of registration\n* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable\n* No history of allergic reaction to the drug excipients",{"count":305,"type":21},160,[52],"This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.",[309,310,311],"Non-Muscle Invasive Bladder Urothelial Carcinoma","Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma","Stage I Bladder Cancer AJCC v8",{"date":108,"type":32},{"date":314,"type":32},"2025-06-03",{"date":316,"type":21},"2032-02-01",{"name":66,"class":67},136,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100589739","phase-3-testing-higher-dose-radiation-therapy-for-locally-advanced-pancreatic-cancer-100589739","NCT06958328","Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer","A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)","LAP100","Inclusion Criteria:\n\n* At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine\u002Fnab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. \"Active chemotherapy\" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle\n* BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n* Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma\n* Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \\[NCCN\\] guidelines and institutional tumor board review)\n* Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment\n* Age ≥ 18 years\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2\n* Required initial laboratory values:\n\nAll laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy\n\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)\n* BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria\n\n  * If baseline CA19-9 \\> 37 U\u002FmL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe \\[up to 30 days post chemotherapy initiation\\])\n  * If baseline CA19-9 U\u002FmL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value\n\n    * Prior radiation treatment\n* Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted\n* If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford\n\n  * POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n  * If baseline CA19-9 is elevated (defined as \\> 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u\u002FmL or a 50% decline from pre-chemotherapy level with absolute value less than 100u\u002FmL\n  * If baseline CA19-9 is not elevated (defined as ≤ 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u\u002FmL\n  * No active duodenal or gastric ulcers\n  * No direct tumor invasion of the bowel or stomach\n  * Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, or CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment, with restaging CT showing at least stable disease\n  * Not pregnant and not nursing\n  * No cardiac condition that was the primary reason for hospitalization in the last 6 months\n  * New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",{"count":328,"type":21},356,[24],"This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.",[332,333,334,335],"Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-08-14",{"date":230,"type":32},{"date":339,"type":32},"2025-08-21",{"date":341,"type":21},"2035-10-21",{"name":343,"class":116},"NRG Oncology",322,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},"100441586","phase-1-preoperative-radiosurgery-for-the-treatment-of-high-grade-glioma-neoglioma-trial-100441586","NCT05030298","Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial","Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \\[WHO\\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status\n* Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment\n* Planned neurosurgical resection of tumor\n* Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Negative pregnancy test done =\\\u003C 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide written informed consent\n* Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration\n* Willing to provide tissue and\u002For blood samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women who are unwilling to cease during therapy\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Prior history of cranial radiotherapy\n* Unwillingness to participate in study\n* Investigator discretion that enrollment on the study would pose undo harm or risk to the patient\n* Non-MRI compatible implanted medical device\n* Use of systemic anti-cancer therapy within the previous 3 months\n* Medical contraindication to craniotomy and tumor resection\n* Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor\n\n  * Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor\n* Primary spinal cord glioma or primary brainstem glioma\n* Residual tumor of excessive volume or eloquent location per investigator discretion\n* Patients who are unwilling or unable to comply with study procedures",{"count":353,"type":21},28,[173],"This phase I trial finds out the possible benefits and\u002For side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.",[176],{"date":230,"type":32},{"date":359,"type":32},"2023-05-23",{"date":361,"type":21},"2027-09-15",{"name":208,"class":116},2,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":216,"minAge":147,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":117},"100608491","phase-2-metabolic-interventions-time-restricted-eating-glp1-receptor-agonist-and-heart-healthy-diet-to-improve-cardiometabolic-health-in-prostate-cancer-patients-during-androgen-deprivation-therapy-impact-adt-trial-100608491","NCT07202247","Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial","A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* English, Spanish or Mandarin-speaking\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Male\n* Aged: 30-79\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* High burden of cardiovascular comorbidities who would be eligible for insurance coverage for GLP1-RA therapy defined as:\n\n  * Body mass index (BMI) of ≥ 30 kg\u002Fm\\^2 or\n  * BMI ≥ 27 kg\u002Fm\\^2 in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, dyslipidemia)\n* Prostate cancer defined as one of the following:\n\n  * National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer receiving definitive radiation with a plan to undergo ADT for 6 months\n  * Biochemical persistent or recurrent prostate cancer status post prostatectomy receiving salvage radiation with a plan to undergo ADT for 6 months\n\nExclusion Criteria:\n\n* Currently engaging in strict macronutrient\u002Ftime limited diet, including ketogenic, low-carb, paleo, or warrior diet\n* Currently under GLP1-RA therapy\n* Poorly controlled diabetes\n* Unable to undergo time-restricted diet\n* Contraindications for GLP1-RA therapy: including hypersensitivity to the drug, personal history of pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, end-stage renal disease\n* Other active disease deemed not eligible to participant in the study according to treating physician\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","79 Years",{"count":373,"type":21},60,[52],"This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related metabolic changes which may result in increased weight, body fat, insulin resistance and an increased risk of heart attack, stroke or other heart and blood vessel problems. TRE (also known as intermittent fasting) is an eating plan that alternates between fasting and non-fasting periods. This approach limits calorie intake to a specific window of time each day. GLP1-RAs, semaglutide and tirzepatide are in a class of medications called incretin mimetics. They work by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. They also slow the movement of food through the stomach and may decrease appetite and cause weight loss. The AHA HHD guidelines may be an effective method to help people learn about following a heart healthy eating plan. This may lower their risk of cardiovascular disease. Metabolic interventions, TRE and GLP1-RA, may be more effective than an AHA HHD intervention alone in improving cardiovascular and metabolic health in prostate cancer patients undergoing ADT.",[377,378],"Prostate Carcinoma","Recurrent Prostate Carcinoma","2026-08-13",{"date":230,"type":32},{"date":382,"type":32},"2025-11-05",{"date":384,"type":21},"2028-04-09",{"name":386,"class":116},"City of Hope Medical Center",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":402,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":117},"100542535","phase-1-hypofractionation-trial-of-re-irradiation-in-good-prognosis-recurrent-glioblastoma-100542535","NCT06344130","Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","* INCLUSION CRITERIA:\n* Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.\n* Age \\>= 18.\n* KPS \\>= 70%.\n* Previous tumor irradiation to curative-intent doses.\n* Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmicroL\n  * Platelets \\>= 100,000\u002FmicroL\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Recent systemic therapy prior to the initiation of the study therapy as follows:\n\n  * Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.\n  * Temozolomide within 2 weeks.\n  * Cytotoxic chemotherapy within 3 weeks.\n  * Any investigational agents within 2 weeks.\n* Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.\n* Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.\n* Requiring radiation therapy within 12 months prior to the initiation of study therapy.\n* History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.\n* Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.\n* Participants with known or suspected radiation sensitivity syndromes.\n* Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.","120 Years",{"count":353,"type":21},[173],"Background:\n\nGlioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.\n\nObjective:\n\nTo find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.\n\nEligibility:\n\nPeople aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.\n\nParticipants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.\n\nParticipants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.\n\nParticipants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.\n\nParticipants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.",[399,400,401],"Astrocytoma","Glioma","Recurrent Glioblastoma",[403,404,405],"Radiotherapy","Hypofractionation","Re-irradiation",{"date":336,"type":32},{"date":408,"type":32},"2024-10-01",{"date":410,"type":21},"2027-12-31",{"name":66,"class":67},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":434},"100454537","phase-2-testing-the-addition-of-an-anti-cancer-drug-trc102-to-the-usual-chemotherapy-treatment-pemetrexed-cisplatin-or-carboplatin-during-radiation-therapy-for-stage-iii-non-squamous-non-small-cell-lung-cancer-100454537","NCT05198830","Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer","A Phase 2 Randomized Study of the BER Inhibitor TRC102 in Combination With Standard Pemetrexed-Platinum-Radiation in Stage III Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed adenocarcinoma or large cell carcinoma of the lung with confirmation by immunohistochemistry (histologic tissue diagnosis is preferred, but cytology is acceptable).\n* Patients must have newly staged IIIA, IIIB or IIIC disease according to the 8th tumor, node, metastasis (TNM) staging classification and to be considered appropriate candidates for aggressive chemoradiotherapy.\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm (\\>= 2 cm) by chest x-ray or as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam.\n* Patients must have diagnosed NSCLC, with no prior overlapping radiation therapy delivered for locally advanced NSCLC. Prior stereotactic radiation therapy for stage I lung cancer without overlapping is allowed. Prior systemic antineoplastic therapy is allowed, as deemed appropriate by the treating physician. Prior surgery is allowed. History of previous stage I NSCLC with new mediastinal nodal recurrence (new stage III are eligible).\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of TRC102 in combination with pemetrexed, cisplatin, and durvalumab in patients \\\u003C 18 years of age, children are excluded from this study.\n* Body weight \\> 30 kg with acceptable nutritional status based on evaluation by treating physician.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%).\n* Leukocytes \\>= 3,000\u002FmcL.\n* Hemoglobin \\>= 9.0 g\u002FdL.\n* Absolute neutrophil count \\>= 1,500\u002FmcL.\n* Platelets \\>= 150,000\u002FmcL.\n* Serum bilirubin within normal institutional limits (0 - 1.2 mg\u002F dl). (This will not apply to patients with confirmed Gilbert's syndrome \\[persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology\\], who will be allowed only in consultation with their physician.).\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x institutional upper limit of normal (=\\\u003C 39 U\u002FL).\n* Alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal (=\\\u003C 52 U\u002FL).\n* Creatinine =\\\u003C 1.3 mg\u002FdL.\n* Measured creatinine clearance \\>= 60 mL\u002Fmin OR glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2.\n* Acceptable pulmonary function as assessed by treating physician.\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 60 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women \\>= 60 years of age will be considered post-menopausal.\n* Life expectancy \\>= 12 months.\n* Patients who are human immunodeficiency virus (HIV) positive may participate IF they meet the following eligibility requirements:\n\n  * They must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks.\n  * They must have a CD4 count of greater than 250 cells\u002FmcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FmcL over the past 2 years, unless it was deemed related to the cancer and\u002For chemotherapy induced bone marrow suppression.\n\n    * For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FmcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy.\n  * They must have an undetectable viral load and a CD4 count \\>= 250 cells\u002FmcL within 7 days of enrollment.\n  * They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.\n  * HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better.\n* The effects of TRC102 on the developing human fetus are unknown. For this reason and because biochemical inhibitors of the BER pathway agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of durvalumab monotherapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of durvalumab administration, if having sex with women of childbearing potential.\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible.\n* Patients with prior stage I\u002FII non-small cell lung cancer treated with surgery are eligible. Patients with prior stage I NSCLC treated with stereotactic body radiotherapy (SBRT) without overlapping radiation fields would also be eligible. Patients with prior chemotherapy are eligible, at physician's discretion.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents.\n* Patients with treated brain metastases are not eligible as the study is for stage III disease only.\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are not eligible as the study includes only stage III disease.\n* Patients with EGFR or ALK mutations are ineligible.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC102 or other agents used in study.\n* Patients with uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because TRC102 is a biochemical inhibitor of the BER pathway and durvalumab is an anti-PDL1 antibody, agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TRC102 or durvalumab, breastfeeding should be discontinued if the mother is treated with TRC102 or durvalumab. These potential risks may also apply to other agents used in this study.\n\n  * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after durvalumab monotherapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of durvalumab.\n* Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia.\n  * Patients with hypothyroidism (e.g. following Hashimoto thyroiditis) stable on hormone replacement.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician.\n  * Patients with celiac disease controlled by diet alone.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis \\[TB\\] testing in line with local practice), hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).\n* History of allogenic organ transplantation.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no active disease before the first dose of investigational product (IP) and of low potential risk for recurrence.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated any carcinoma in situ without evidence of disease.\n  * Prostate cancer with stable disease with active or prior treatment that will not interfere with current lung cancer treatment will be eligible.",{"count":420,"type":21},42,[52],"This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is in a class of drugs called antineoplastic agents. It blocks the ability of a cell to repair damage to its deoxyribonucleic acid (DNA) and may kill tumor cells. It may also help some anticancer drugs work better. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC.",[424,425,426,427],"Lung Adenocarcinoma","Lung Large Cell Carcinoma","Lung Non-Squamous Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","2026-08-12",{"date":379,"type":32},{"date":431,"type":32},"2022-12-15",{"date":181,"type":21},{"name":66,"class":67},34,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":139},"100408110","nodal-radiation-therapy-for-sentinel-lymph-node-positive-melanoma-100408110","NCT04594187","Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma","The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma","MelPORT","Inclusion Criteria:\n\n* Must be planned for post-operative immunotherapy\n* No evidence of distant metastasis as determined by clinical examination and any form of imaging\n* No evidence of clinically involved lymph nodes prior to SLNB\n* Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension \\[ECE\\] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)\n* Has provided written informed consent for participation in this trial\n* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less\n* Life expectancy greater than 6 months\n* Patients capable of childbearing are using adequate contraception\n* Available for follow-up\n\nExclusion Criteria:\n\n* Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN\n* Distant metastasis\n* Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues\n* Women who are pregnant\n* Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study",{"count":444,"type":21},168,[52],"This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.",[448],"Melanoma","2026-08-07",{"date":451,"type":32},"2026-08-10",{"date":453,"type":32},"2020-08-07",{"date":410,"type":21},{"name":456,"class":116},"M.D. Anderson Cancer Center",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},"100393420","testing-the-addition-of-radiation-therapy-to-the-usual-immune-therapy-treatment-atezolizumab-for-extensive-stage-small-cell-lung-cancer-the-raptor-trial-100393420","NCT04402788","Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial","RAndomized Phase II\u002FIII Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial","Inclusion Criteria:\n\n* Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases\n* Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide\u002Fplatinum (E\u002FP) doublet plus atezolizumab by re-staging scans (positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] scan, diagnostic CT scan, magnetic resonance imaging \\[MRI\\] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide\u002Fplatinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)\n\n  * NOTE: Patients must have at least 3 cycles of E\u002FP plus atezolizumab. They can have one cycle of induction E\u002FP without concurrent atezolizumab if unable to receive concurrent E\u002FP combined with atezolizumab for all cycles of induction therapy\n* Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment\n* At time of enrollment after induction E\u002FP chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT\u002FPET imaging\n* Appropriate stage for study entry based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 14 days prior to registration;\n  * Imaging within 42 days prior to registration to include:\n\n    * MRI brain with contrast or CT brain with contrast\n    * CT chest, abdomen and pelvis or whole body PET\u002FCT scan any time after the fourth cycle of chemotherapy and prior to registration\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fcells\u002Fmm\\^3 (within 14 days prior to registration)\n* Platelets \\>= 75,000 cells\u002Fmm\\^3 (within 14 days prior to registration)\n* Hemoglobin \\>= 8 g\u002FdL (within 14 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN (AST and\u002For ALT =\\\u003C 5 ULN for patients with liver involvement) (within 14 days prior to registration)\n* Alkaline phosphatase =\\\u003C 2.5 x ULN (=\\\u003C 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)\n* Adequate renal function = Creatinine clearance \\>=40 mL\u002Fmin by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)\n* Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture\n* Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily\n* For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.\n\n  * Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n    * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\n    * Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)\n* Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* Metastatic disease invading the liver (\\> 3 metastases), heart or \\> 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site\n* Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation\n* Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue\n* Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.\n\n  * If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.\n  * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n  * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.\n* Severe, active co-morbidity defined as follows:\n\n  * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;\n  * Active tuberculosis;\n  * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\n\n    * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible\n    * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)\n  * Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);\n  * Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of \\> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 3 months;\n  * History of recent myocardial infarction within 6 months prior to registration.\n  * Clinically significant interstitial lung disease\n* Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women who are breastfeeding and unwilling to discontinue\n* History of allogeneic organ transplant\n* Patients who have had immunotherapy-induced pneumonitis",{"count":465,"type":21},138,[52,24],"This phase II\u002FIII trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.",[469],"Extensive Stage Lung Small Cell Carcinoma",{"date":451,"type":32},{"date":472,"type":32},"2021-01-07",{"date":474,"type":21},"2027-04-30",{"name":66,"class":67},415,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":484,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":363},"100526054","phase-2-repeat-breast-conserving-surgery-followed-by-daily-partial-breast-irradiation-in-ipsilateral-breast-100526054","NCT06129747","Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast","Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy","Inclusion Criteria:\n\n* Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.\n* Lesion size \\\u003C 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.\n* Negative resection margins with at least no tumor on ink or a negative re-excision.\n* Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest\u002Fabdomen and a bone scan or a PET scan.\n* Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.\n* Participants must be \\> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Performance status: ECOG Performance status ≤ 2.\n* Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.\n* Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.\n\nExclusion Criteria:\n\n* Participants with nodal or distant metastatic disease \\\u003C 3 years since prior radiation.\n* Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.\n* Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.\n* Participants with Paget's disease of the nipple.\n* Participants with skin involvement.\n* Participants with scleroderma or dermatomyositis.\n* Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.\n* Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.\n* Participants with known BRCA 1\u002FBRCA 2 mutations.","19 Years",{"count":486,"type":21},55,[52],"The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.",[490,491],"Breast Cancer","Tumor, Breast",[227,493,494,405],"In-Breast Recurrence","Tumor","2026-08-04",{"date":497,"type":32},"2026-08-06",{"date":499,"type":32},"2023-11-30",{"date":501,"type":21},"2029-08-09",{"name":503,"class":116},"Case Comprehensive Cancer Center",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":511,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100525624","phase-2-a-study-testing-the-combination-of-dasatinib-or-imatinib-to-chemotherapy-treatment-with-blinatumomab-for-children-adolescents-and-young-adults-with-philadelphia-chromosome-positive-ph-or-abl-class-philadelphia-chromosome-like-ph-like-b-cell-acute-lymphoblastic-leukemia-b-all-100525624","NCT06124157","A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients must be \\> 365 days and \\\u003C 18 years (for AIEOP-BFM), \\> 365 days and \\\u003C 22 years (for Children's Oncology Group \\[COG\\]) and \\> 365 days and \\\u003C 46 years (for ALLTogether sites) at the time of enrollment\n* Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and\u002For dasatinib: ABL1, ABL2, CSF1R, and PDGFRB\n* Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment\n* Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and\u002For other standard cytotoxic chemotherapy\n* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine\n* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)\n* Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2\n  * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard\n* For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34.2 micromoles\u002FL) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* \\* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) OR\n\n  * Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) AND\n  * Corrected QT Interval, QTc \\\u003C 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\])\n\n    * Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment\n\nExclusion Criteria:\n\n* Known history of chronic myeloid leukemia (CML)\n* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase\n* ALL developing after a previous cancer treated with cytotoxic chemotherapy\n* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation\n* Down syndrome (trisomy 21)\n* Pregnancy and breast feeding\n\n  * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment\n  * Lactating females who plan to breastfeed their infants\n  * Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol\n\n    * NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer\n* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib\n* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","366 Days","46 Years",{"count":514,"type":21},222,[52],"This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes\u002Fcells\u002Fmolecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.",[518],"B Acute Lymphoblastic Leukemia",{"date":520,"type":32},"2026-08-05",{"date":522,"type":32},"2025-05-30",{"date":524,"type":21},"2030-12-01",{"name":66,"class":67},156,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":542,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":117},"100374167","petct-changes-during-chemoimmunotherapy-and-radiation-therapy-in-patients-with-stage-iv-non-small-cell-lung-cancer-100374167","NCT04151940","PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer","An Interventional Study of PET\u002FCT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)","Inclusion Criteria:\n\n* Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \\[AJCC\\]\u002FUnion for International Cancer Control \\[UICC\\] 8th edition for staging)\n* Evidence of stage IV disease on imaging by CT, PET\u002FCT, or magnetic resonance imaging (MRI)\n* Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor\n* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion\n* Subjects must be ≥ 18 years of age\n* Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Creatinine =\\\u003C 2 mg\u002FdL or creatinine clearance \\> 50 mL\u002Fmin\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5x institutional upper limit of normal\n* Total bilirubin =\\\u003C 1.5 mg\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\>= 1500 per mm\\^3)\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\>=100,000 per mm\\^3)\n* Capability to understand and comply with the protocol requirements and signed informed consent documents\n\nExclusion Criteria:\n\n* Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \\>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)\n* Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms\n* Has any serious or uncontrolled active infection that could create false positives on a PET\u002FCT scan, in the opinion of the treating investigator\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)\n\n  \\*\\*Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has known, active, and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n\n  * Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day",{"count":535,"type":21},80,[195],"This study investigates the changes in positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET\u002FCT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.",[539,540,541],"Metastatic Lung Non-Small Cell Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8",[543],"Lung",{"date":497,"type":32},{"date":546,"type":32},"2019-09-26",{"date":548,"type":21},"2027-11-30",{"name":550,"class":116},"University of Washington",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":117},"100650609","phase-2-smad4-tailored-neoadjuvant-therapy-for-the-treatment-of-resectable-and-borderline-resectable-pancreatic-ductal-adenocarcinoma-smart-panc-trial-100650609","NCT07748611","SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial","SMART-PANC: SMAD4 Tailored Neoadjuvant Therapy for Pancreatic Cancer, A Phase ll Non-Randomized, Single Center Pilot Study","Inclusion Criteria:\n\n* Patients must have histologically confirmed pancreas ductal adenocarcinoma\n\n  * Most recent cross-sectional imaging of the chest, abdomen and pelvis will be used to rule out distant metastases (this will have been completed within standard of care timelines which will typically fall within 90 days of registration)\n* Patients must have undergone next generation sequencing (NGS) testing on the pre-treatment tumor tissue and must have either SMAD4 mutant or SMAD4 wild-type mutation identified before consenting for this study\n\n  * Note: Before consenting to this study, standard of care NGS procedure will be performed on pre-treatment tumor biopsies that are routinely collected through endoscopic biopsy specimens (in-house Oncomine Precision NGS). The results will be documented for this study from clinic notes\n* Patients must have resectable\u002Fborderline-resectable disease\n\n  * Note: National Comprehensive Cancer Network (NCCN) definitions of resectability will be used\n* Patients must be treatment-naïve and clinically fit and eligible for either FOLFIRINOX or gemcitabine\u002Fnab-paclitaxel chemotherapy regimens (per treating physician's determination)\n* Patients must be ≥ 18 years of age\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patients must have adequate organ and bone marrow function as determined by the treating physician to be considered to be clinically fit for the physician-determined chemotherapy regimen\n* Patients must agree to use adequate contraception: (e.g. hormonal or barrier method of birth control for a patient of child-bearing potential (POCBP), prior to study entry, and for the duration of study participation. Should a female patient, or a female partner of a patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study doctor immediately. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through the time period indicated for standard of care drugs , after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy\n  * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative pregnancy test prior to registration on study\n* Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements\n\nExclusion Criteria:\n\n* Patients with the presence of any of the following genetic or molecular abnormalities:\n\n  * Mismatch repair (MMR)-deficiency\u002FLynch syndrome\n  * High-frequency microsatellite instability (MSI-H)\n  * Homologous recombination deficiency (HRD)\n* Patients who are currently participating in another study and receiving a study drug\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (per treating physician's determination)\n* Patients who are pregnant or nursing\n* Patients who have an uncontrolled intercurrent illness (as determined by treating physician), including, but not limited to any of the following:\n\n  * Hypertension that is not controlled on medication\n  * Active infection requiring treatment\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n* Patient with presence of any concurrent medical or psychiatric condition\u002Fsocial situations which would make them inappropriate candidates for entry into this study or that would limit compliance with study requirements, or would compromise the patient's safety or study endpoints, in the treating investigator's judgment",{"count":559,"type":21},125,[52],"This phase II trial tests the impact of using SMAD4-mutant status to personalize chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) that can be removed by surgery (resectable) or that may be between resectable and unresectable (borderline resectable) before undergoing surgery (neoadjuvant). PDAC is one of the most aggressive and fastest growing tumors. SMAD4, a tumor suppressor gene, acts like a brake on cell growth and helps to prevent tumor cells from growing. However, losing it makes the tumor more aggressive and often resistant to standard of care (SOC) treatments regimens, such as gemcitabine with nab-paclitaxel and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic (DNA) and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Instead of a one-sized fits all treatment approach with SOC therapies, matching therapy based on SMAD4 mutation status may use this specific genetic weakness against the tumor. This approach to neoadjuvant therapy may dramatically alter the path of treatment and improve outcomes, including complete resection rates, in patients with resectable or borderline resectable PDAC.",[563,564],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","Resectable Pancreatic Ductal Adenocarcinoma","2026-07-31",{"date":497,"type":32},{"date":568,"type":21},"2027-02-03",{"date":570,"type":21},"2031-02-03",{"name":572,"class":116},"Northwestern University",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":580,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":591,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":363},"100564069","phase-1-atovaquone-combined-with-radiation-in-children-with-malignant-brain-tumors-100564069","NCT06624371","Atovaquone Combined With Radiation in Children With Malignant Brain Tumors","AflacBT2303","Inclusion Criteria:\n\n-Stratum 1\n\n* Newly diagnosed pHGG\u002FDMG\u002FDIPG Patients must have histologically confirmed pediatric high-grade glioma (pHGG, WHO Grade 3 or 4) or diffuse midline glioma with altered H3K27 (DMG, WHO Grade 4). Primary pHGG or DMG spinal tumors are eligible. Diffuse intrinsic pontine glioma (DIPG) defined by MRI does not require histological confirmation.\n* Weight \\> 10kg\n* Karnofsky and Lansky performance score \\> 50%\n* Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.\n* Adequate liver function defined as:\n\n  * Total bilirubin ≤ 2x upper limit of normal (ULN) and\n  * AST (SGOT) and ALT (SGPT) ≤ 225 U\u002FL (5x the ULN). The ULN for AST and ALT will be 45 U\u002FL.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\> 1,000\u002FmcL\n  * platelets \\> 100,000\u002FmcL\n  * hemoglobin \\> 8g\u002FdL\n  * Total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 5 x (\\\u003C10 x if taking steroids) the institutional upper limit of normal\n  * creatinine within normal institutional limits for age 2 OR\n  * creatinine clearance \\> 60mL\u002Fmin\u002F1.73 m for patients with creatinine levels above institutional normal\n\nStratum 2\n\n* Relapsed, progressive pHGG\u002FDMG\u002FDIPG and medulloblastoma (MB) or pHGG\u002FDMG\u002FDIPG after completion of standard radiation therapy without prior atovaquone exposure and before progression. Patients with metastatic disease are allowed for Stratum 2 only.\n\n  --Measurable disease is not necessary for enrollment study.\n* Patients must have previously undergone standard-of-care treatment including surgery, radiation, and\u002For first-line adjuvant chemotherapy before the experimental treatment (atovaquone).\n* Patients must have recovered from the acute treatment-related toxicities (defined as \\\u003C grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study. There is no upper limit to the number of prior therapies that is allowed.\n* Age \\> 2 to 25 years\n* Weight \\> 10kg\n* Karnofsky and Lansky performance score \\> 50%\n* Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.\n* Patients must have normal organ and marrow function as defined above for Stratum 1\n* Adequate liver function is defined as:\n\n  1. Total bilirubin ≤ 2x upper limit of normal (ULN) and\n  2. AST (SGOT) and ALT (SGPT) ≤ 225 U\u002FL (5x the ULN). The ULN for AST and ALT will be 45 U\u002FL.\n\nExclusion Criteria:\n\nStratum 1\n\n* Chronic systemic concurrent illness\n* Concurrent or history of anti-cancer therapy other than RT\n* Patients with metastatic tumor are excluded for Stratum 1 only.\n* Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.\n* Patients must fully recover from all acute effects of prior surgical intervention.\n* History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.\n* Symptomatic intratumoral hemorrhage, or asymptomatic intratumoral hemorrhage larger than punctate foci, at any time prior to enrollment.\n* Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion.\n\nStratum 2\n\n* Concurrent illness\n* Patients must have recovered from all prior therapy as follows:\n\n  1. Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks before study enrollment or at least six (6) weeks if prior nitrosourea.\n  2. Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent ≥ 7 days before study enrollment.\n  3. Antibodies: ≥ 21 days must have elapsed from an infusion of the last dose of antibody and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1. Agents with prolonged half-lives: At least three half-lives must have elapsed before enrollment.\n  4. Immunotherapy: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses. etc.) at least 42 days before enrollment.\n  5. Radiation: Patients must have had their last fraction of • Craniospinal irradiation ≥ 3 months before enrollment. • Other substantial bone marrow irradiation ≥ 6 weeks before enrollment • Local or palliative XRT (small port) ≥ 2 weeks.\n  6. Stem Cell Transplant: Patient must be ≥ 12 weeks since autologous bone marrow\u002Fstem cell transplant before enrollment. Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.\n* Patients must fully recover from all acute effects of prior surgical intervention.\n* History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.\n* Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion.","2 Years","25 Years",{"count":583,"type":21},18,[173],"The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma\u002Fdiffuse midline glioma\u002Fdiffuse intrinsic pontine glioma (pHGG\u002FDMG\u002FDIPG).\n\nThe secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG\u002FDMG\u002FDIPG and medulloblastoma (MB) or pHGG\u002FDMG\u002FDIPG after completion of RT and before progression.",[587,588,589,590],"High-grade Glioma","Medulloblastoma","Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant",[592,593],"Atovaquone","Progression-free survival","2026-07-30",{"date":596,"type":32},"2026-08-03",{"date":598,"type":32},"2025-03-28",{"date":600,"type":21},"2027-10",{"name":602,"class":116},"Emory University",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":610,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":613,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":633},"100430983","phase-3-jnj-90301900-nbtxr3-activated-by-radiotherapy-with-or-without-cetuximab-in-la-hnscc-100430983","NCT04892173","JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC","A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Age greater than or equal to (\\>=) 60 years old\n* Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab\n* Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC\n* One primary tumor lesion amendable for intratumoral injection\n* Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):\n\n  1. Estimated creatinine clearance \\>= 30 and less than (\\\u003C) 50 milliliters\u002Fminute (mL\u002Fmin) (per Cockcroft-Gault equation),\n  2. Grade \\>= 2 hearing loss or tinnitus,\n  3. Grade \\>= 2 peripheral neuropathy,\n  4. New York Heart Association Class 3\n  5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\\\u003C=) 14 or Aged \\>= 75 years old\n* Eastern cooperative oncology group (ECOG) performance status 0 to 1\n* Life expectancy \\>= 6 months\n\nExclusion Criteria:\n\n* Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin\n* Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC\n* Loco-regionally recurrent head \\& neck cancer that has been previously treated with surgery, radiation therapy, and\u002For chemotherapy\n* Prior or concurrent primary malignancy (including second synchronous head \\& neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent\n* Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization","60 Years",{"count":612,"type":21},500,[24],"This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) \u002F radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).",[616],"Carcinoma, Squamous Cell",[618,619,620,621,403,622,623,624],"LA-HNSCC","NBTXR3","hafnium oxide","radioenhancer","RT","HNSCC","radiation therapy",{"date":565,"type":32},{"date":627,"type":32},"2021-12-10",{"date":629,"type":21},"2028-06-30",{"name":631,"class":632},"Johnson & Johnson Enterprise Innovation Inc.","INDUSTRY",193,""]