[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stereotactic-body-radiation-therapy-sbrt\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stereotactic-body-radiation-therapy-sbrt":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,83,106,134,157,186,221],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100572814","phase-2-the-efficacy-and-safety-of-narlumosbart-in-combination-with-stereotactic-body-radiation-therapy-to-improve-the-efficacy-of-first-line-chemotherapy-combined-with-immunotherapy-in-patients-with-bone-metastases-from-advanced-non-small-cell-lung-cancer-100572814",false,"NCT06738160","The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer","Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy Followed by First-line Chemotherapy Combined With Immunotherapy in Advanced Driver Gene-negative Non-small Cell Lung Cancer Patients With Bone Metastases: A Phase II, Single-arm, Single-center Clinical Trial Protocol","Inclusion Criteria:\n\n* Signed informed consent prior to the implementation of any trial-related procedures;\n* Age 18-80 years old;\n* Histologically or cytologically confirmed stage IV NSCLC according to the TNM Classification of Malignant Tumours, 9th edition；\n* Histologically confirmed bone metastases requiring local radiotherapy；\n* Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);\n* Driver genes (EGFR, ALK, ROS-1) negative in adenocarcinoma patients (genetic testing not required for squamous cell carcinoma) ;\n* At least one evaluable non-bone lesion (refer to RECIST1.1);\n* Bone metastases other than the lesions to be radiotherapy do not require local treatment (surgery or radiotherapy) intervention after evaluation;\n* ECOG score 0-1 points;\n* Expected survival time \\> 3 months;\n* Adequate organ function, defined as meeting all of the following laboratory criteria within 14 days prior to enrollment: 1) ANC ≥1.5×10⁹\u002FL (no G-CSF); 2) Platelets ≥100×10⁹\u002FL (no transfusion); 3) Haemoglobin ≥9 g\u002FdL (no transfusion\u002FEPO); 4) Bilirubin ≤1.5×ULN; 5) AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases); 6) Creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin; 7) INR\u002FPT ≤1.5×ULN; 8) TSH within normal limits (or FT3\u002FFT4 normal if TSH abnormal); 9) Cardiac enzymes (troponin I, CK-MB) ≤ ULN (isolated abnormalities not clinically significant are permitted).\n\nExclusion Criteria:\n\n* The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;\n* The lesion is an isolated lesion and can be treated radically;\n* Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;\n* The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;\n* Presence of active brain metastases;\n* Other malignancies within 5 years (except cured non-melanoma skin cancer or carcinoma in situ);\n* Prior treatment with anti-PD-1, anti-PD-L1, or RANKL-targeting agents;or used investigational device treatment within 4 weeks prior to the first dose;\n* Active autoimmune disease requiring systemic therapy;\n* Presence of clinically uncontrollable pleural effusion\u002Fascites effusion (subjects who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled);\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Presence of active bone metabolism disease (Paget bone disease, Cushing's syndrome, and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper\u002Fhypothyroidism, hyperparathyroidism\u002Fhypoparathyroidism;\n* Those who are known to be allergic to the active ingredients or excipients such as sintilimab, pemetrexed, nalusopaimab, carboplatin, cisplatin, paclitaxel, etc., of the drug in this study;\n* Have not recovered adequately from toxicity and\u002For complications induced by any of the interventions (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the research center);\n* Hypocalcemia cannot be improved after treatment;\n* Previous or current osteomyelitis or osteonecrosis of the jaw; Dental surgery or oral surgery that does not heal; Acute dental or jaw disease requiring oral surgery; Those who plan to undergo invasive dental surgery during the study;\n* Use of any of the following anti-bone metabolizing agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or derivatives; Calcitonin; Osteoprotein; Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1);\n* Pregnant or lactating women;\n* Presence of any serious or uncontrollable systemic disease, such as:\n\n  1. Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;\n  2. unstable angina, congestive heart failure, New York Heart Association (NYHA) classification ≥ grade 2 chronic heart failure;\n  3. myocardial infarction within 6 months prior to enrollment;\n  4. unsatisfactory blood pressure control;\n  5. History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease;\n  6. active tuberculosis;\n  7. Presence of active or uncontrolled infection requiring systemic therapy;\n  8. Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. poorly controlled diabetes mellitus (fasting blood glucose (FBG) \\>10mmol\u002FL);\n  11. Those whose urine routine showed a urine protein ≥++, and confirmed that the 24-hour urine protein was \\> 1.0 g;\n  12. Subjects with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other conditions that are considered by the investigator to be unsuitable for enrollment in the opinion of the investigator are not suitable for participation in this study.","ALL","18 Years","80 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases.\n\nMethods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg\u002Ftime, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy\u002F3F is used for spinal metastases, and 30Gy\u002F5F or 35Gy\u002F5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR\u002FPR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR\u002FPR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.\n\nWangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.",[27,28,29],"NSCLC","Stereotactic Body Radiation Therapy (SBRT)","Immunotherapy","RECRUITING","2026-07-21",{"date":33,"type":34},"2026-07-23","ACTUAL",{"date":36,"type":34},"2025-02-15",{"date":38,"type":21},"2028-12-30",{"name":40,"class":41},"Fudan University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":42},"100625704","phase-2-pro-boost-n-prostate-first-versus-combined-prostate-and-nodal-dose-escalation-in-psma-pet-staged-node-positive-prostate-cancer-100625704","NCT07426094","PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer","PRO-BOOST-N: A Randomized Phase II\u002FIII Trial Evaluating Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer Using an Ultrahypofractionated Whole-Pelvis Radiotherapy Platform","PRO-BOOST-N","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.\n* Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and\u002For PSMA PET\u002FCT.\n* No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.\n* Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.\n* Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy.\n* Age ≥18 years.\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.\n* Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.\n* Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.\n* History of castration-resistant prostate cancer.\n* Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes.\n* Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy.\n* Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.","MALE",{"count":53,"type":21},600,[24,55],"PHASE3","PRO-BOOST-N is a prospective, multicenter, randomized phase II\u002FIII clinical trial for patients with prostate cancer and pelvic lymph node involvement (cN1M0) confirmed by PSMA PET\u002FCT, without distant metastatic disease.\n\nPatients with PSMA PET-staged node-positive prostate cancer are potentially curable, but remain at substantial risk of distant progression despite contemporary treatment with radiotherapy, long-term androgen deprivation therapy, and, when appropriate, androgen receptor pathway inhibitors. The optimal way to intensify radiotherapy to the prostate and PSMA PET-positive pelvic lymph nodes remains uncertain in the era of modern molecular imaging.\n\nAll participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy backbone delivered in five fractions, combined with long-term systemic therapy according to contemporary clinical practice. The study uses a 2 x 2 factorial randomized design to evaluate two treatment questions.\n\nThe primary comparison evaluates whether prostate dose escalation improves metastasis-free survival compared with no additional prostate boost. Patients assigned to prostate boost receive one of three protocol-defined boost techniques: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT. If more than one prostate boost technique is available at the treating center and technically suitable for the patient, the boost technique is assigned by embedded subrandomization.\n\nThe key secondary, hierarchically tested comparison evaluates nodal dose escalation by comparing two predefined dose levels to PSMA PET-positive pelvic lymph nodes. Organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm when required for patient safety and protocol compliance.\n\nThe primary endpoint is metastasis-free survival (MFS) . Secondary endpoints include overall survival (OS), radiographic progression-free survival (rPFS), intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related adverse events graded according to CTCAE version 6.0, and patient-reported quality of life, including urinary, bowel, sexual, and global health domains.\n\nPRO-BOOST-N aims to determine the optimal radiotherapy intensification strategy for patients with PSMA PET-staged node-positive prostate cancer by prospectively evaluating prostate-directed and nodal-directed dose escalation within a modern, standardized radiotherapy platform.",[58,59,28,60,61],"Prostate Cancer","Brachytherapy","Dose Escalation: Solid Tumors","Regionally Advanced Prostate Cancer",[63,64,65,59,66,67,68,69,70,71,72,73,74],"Radiotherapy","Stereotactic Body Radiotherapy","SBRT","High-Dose-Rate Brachytherapy","Low-Dose-Rate Brachytherapy","Dose Escalation","Ultrahypofractionation","PSMA PET","Prostate-Specific Membrane Antigen","Metastasis-Free Survival","Nodal metastases","Metastases","2026-07-18",{"date":31,"type":34},{"date":78,"type":34},"2026-03-19",{"date":80,"type":21},"2035-12-01",{"name":82,"class":41},"Affidea Nu-med Center of Oncological DIagnostics and Therapy",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":42},"100625701","phase-2-pro-boost-lc-whole-gland-boost-strategies-versus-sbrt-monotherapy-in-psma-staged-localized-and-locally-advanced-prostate-cancer-100625701","NCT07426055","PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer","PRO-BOOST-LC: A Prospective, Multi-arm Phase II\u002FIII Clinical Trial Evaluating the Efficacy and Safety of Whole-Gland Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT Following an Ultrahypofractionated EBRT (VMAT) Backbone (5 Gy x 5 Fractions) Compared to Standard SBRT Monotherapy in Patients With Localized and Locally Advanced Prostate Cancer Staged With PSMA PET\u002FCT","PRO-BOOST-LC","Inclusion Criteria:\n\n* Male patients aged ≥18 years.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.\n* Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.\n* NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.\n* Candidate for definitive radiotherapy with curative intent.\n* ECOG performance status 0-2.\n* Baseline PSA available prior to randomization.\n* Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol.\n* Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.\n* Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.\n* Prior pelvic radiotherapy for any malignancy.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.\n* History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).\n* Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.\n* Severe uncontrolled comorbidities that would preclude protocol treatment.\n* Inability to comply with study procedures or follow-up schedule.",{"count":92,"type":21},1000,[24,55],"PRO-BOOST-LC is a prospective, multicenter, randomized phase II\u002FIII clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT).\n\nRadiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PET imaging.\n\nThe aim of PRO-BOOST-LC is to compare definitive SBRT monotherapy with whole-gland prostate boost strategies delivered after a short course of external beam radiotherapy. Participants will be randomly assigned, according to center capability and patient-level technical suitability, to one of the protocol-defined treatment options. The control group receives SBRT monotherapy. The experimental groups receive external beam radiotherapy followed by one of three whole-gland boost techniques: HDR brachytherapy, LDR brachytherapy, or single-fraction SBRT boost.\n\nThe primary objective is to determine whether assignment to a prostate boost strategy improves failure-free survival compared with SBRT monotherapy. Failure-free survival includes biochemical recurrence, local or regional progression, distant metastases, progression-driven salvage treatment, or death from any cause. Key secondary outcomes include metastasis-free survival, overall survival, physician-reported treatment-related toxicity, and patient-reported quality of life, including urinary, bowel, and sexual function.\n\nParticipants will undergo baseline clinical evaluation, PSA testing, prostate MRI, PSMA PET\u002FCT, and quality-of-life assessments. After treatment, participants will be followed regularly with clinical assessments, PSA testing, toxicity evaluation, patient questionnaires, and imaging when clinically indicated. The study is designed to provide long-term evidence on how best to use modern radiotherapy dose escalation for patients with PSMA-staged localized or locally advanced prostate cancer.",[96,97,28,60,98],"Prostate Cancer (Adenocarcinoma)","Prostate Brachytherapy","Localized Prostate Cancer",[63,64,65,59,66,67,68,69,70,71,72,100],"Failure-Free Survival",{"date":31,"type":34},{"date":78,"type":34},{"date":104,"type":21},"2035-12",{"name":82,"class":41},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":42},"100592012","practical-geriatric-assessment-in-older-adults-with-non-small-cell-lung-cancer-undergoing-stereotactic-body-radiation-therapy-100592012","NCT06987890","Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy","Lung-GAP","Inclusion Criteria:\n\n* Age ≥ 65 years old at time of study enrollment.\n* Radiographically or pathologically confirmed stage I-II non-small cell lung cancer.\n* All patients must have undergone appropriate complete imaging of their cancer consistent with the standard of care.\n* Patient is expected to undergo stereotactic body radiation therapy (SBRT)\n* Able to read questions in English or willing to complete survey questionnaires with the assistance of an interpreter.\n\nExclusion Criteria:\n\n* There are no exclusion criteria.","65 Years",{"count":115,"type":21},64,[117],"NA","National guidelines recommend that older adults with cancer undergo a special health assessment before starting cancer treatment. This type of assessment evaluates physical function, nutrition, social support, psychological well-being, medical conditions (both cancer-related and non-cancer-related), and cognitive function. The results can help doctors make better treatment decisions and determine whether additional support services-such as nutrition counseling, physical therapy, or social work-would be beneficial. Even though these assessments are recommended, they are not typically used because they need to be performed by a specialist and can take over an hour to complete. Given these challenges, a 10-15-minute assessment called the Practical Geriatric Assessment (PGA) was recently developed. The PGA can be completed by any healthcare provider and helps identify older adults who may need extra support alongside their cancer treatment. While the PGA has the potential to make geriatric assessments more accessible, the investigators do not yet know whether patients will find it useful or easy to complete.\n\nAdditionally, it is unclear whether using the PGA will lead to more referrals for recommended supportive care services. This study aims to address these questions. The investigators will evaluate whether using the PGA impacts the number of patients referred to recommended supportive care services. Investigators will also evaluate how participants feel about completing the PGA, including how easy or difficult it is, and to assess the feasibility of implementing this survey on a larger scale. Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.",[120,121,28],"Lung Cancer (NSCLC)","Geriatric Assessment",[123,124],"Lung Cancer","Geriatric","2026-06-24",{"date":127,"type":34},"2026-06-25",{"date":129,"type":34},"2025-05-26",{"date":131,"type":21},"2026-06-26",{"name":133,"class":41},"Brigham and Women's Hospital",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":42},"100619557","short-interval-postoperative-stereotactic-body-radiation-therapy-sbrt-after-surgical-intervention-for-spine-metastases-100619557","NCT07346170","Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases","A Phase 2 Study of Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases","Inclusion Criteria:\n\n1. Participants must have a histologically or cytologically confirmed diagnosis of metastatic malignancy or must have preliminary histology or cytology consistent with a diagnosis of metastatic malignancy.\n2. Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist.\n3. Participants must have undergone, within the past 13 days, or are planned to undergo minimally invasive or open surgery for the management of a spine metastasis.\n4. Disease at any spine level is allowed.\n5. Prior therapy\n\n   1. There is no limit on the number of prior spine surgeries or prior courses of radiotherapy directed at the spine if prior therapies occurred at different spinal levels outside the anticipated treatment field.\n   2. There is no limit on the number of courses or types of radiotherapy for radiation delivered outside the planned treatment field.\n6. Cleared by the primary surgical team for postoperative SBRT, including but not limited to hemodynamic, respiratory, and neurologic stability postoperatively, without immediate postoperative complications noted.\n7. Age ≥18 years.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix 1) 1 month prior to presentation for surgery.\n9. Estimated survival \\>3 months or survival considered adequate to undergo spine surgery as assessed by the primary surgical team.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Ability to understand and willingness to comply with treatment schedule, follow-up visits, laboratory testing, and other requirements of the study, including disease assessment by MRI.\n12. Individuals 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.\n13. The effects of radiation on the developing human fetus are generally considered detrimental. Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 120 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above).\n2. Primary malignancy of the spine (examples: chordoma or sarcoma).\n3. Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher).\n4. Involvement of 3 or more contiguous spinal levels.\n5. Involvement of more than 2 non-contiguous spinal levels.\n6. American Spinal Injury Association Impairment Scale (ASIA) Grade 3 status.\n7. Surgery was a biopsy only.\n8. Unable to undergo MRI for any reason.\n9. Estimated survival \\\u003C3 months.\n10. Active infection requiring systemic therapy.\n11. Active wound complication requiring medical intervention.\n12. History of radiation-induced myelopathy from prior spine radiation.\n13. History of a collagen vascular disorder (examples: lupus, scleroderma).\n14. History of psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n15. . A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.",{"count":142,"type":21},50,[117],"Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.",[146,28],"Spine Metastasis","NOT_YET_RECRUITING","2026-05-12",{"date":150,"type":34},"2026-05-14",{"date":152,"type":21},"2026-07-15",{"date":154,"type":21},"2027-10-31",{"name":156,"class":41},"University of California, San Francisco",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":167,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":42},"100602271","smc-radiation-oncology-sabr-cohort-for-oligometastasis-100602271","NCT07121335","SMC Radiation Oncology SABR Cohort for Oligometastasis","Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer","SABR-OMOP","Inclusion Criteria:\n\n* Performance status (ECOG PS) 0-2\n* Diagnosed with metastatic disease\n* Confirmed to have oligometastatic\u002Foligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)\n\nExclusion Criteria:\n\n* Patient with a history of prior radiotherapy to the site planned for SABR\n* Patients with concomitant brain metastases",{"count":166,"type":21},60,"3 Years","OBSERVATIONAL","The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.\n\nThe main questions it aims to answer are:\n\n1. oncologic outcomes (progression-free survival, local failure rate),\n2. patient-reported outcomes,\n3. physician-assessed toxicity, and\n4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.",[28,171,172,173,174],"Oligometastasis","Oligoprogression","ctDNA","Patient-Reported Outcomes (PRO)",[176,171,172,173],"Stereotactic body radiotherapy","2025-08-08",{"date":179,"type":34},"2025-08-13",{"date":181,"type":34},"2025-05-01",{"date":183,"type":21},"2030-03-31",{"name":185,"class":41},"Samsung Medical Center",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":205,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":42},"100594316","stereotactic-radiosurgery-as-second-line-therapy-for-ventricular-tachycardia-100594316","NCT07017855","Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia","STAR-4VT","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of enrollment.\n2. Presence of structural heart disease (SHD) of either ischemic or non-ischemic etiology.\n3. Implanted ICD or CRT-D device for primary or secondary prevention of sudden cardiac death (SCD).\n4. History of at least one endocardial CA procedure targeting a substrate of monomorphic sVT.\n5. Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.\n6. Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management.\n7. Provision of written informed consent prior to study participation.\n\nExclusion Criteria:\n\n1. Reversible cause of sVT recurrence, particularly acute coronary syndrome (ACS), acute myocarditis, or lead-related infective endocarditis (LDIE).\n2. Myocardial infarction (MI) or cardiac surgery within the last 40 days.\n3. Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies.\n4. Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved.\n5. Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.\n6. Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.\n7. A mobile thrombus within the left ventricle (LV).\n8. Presence of a left ventricular assist device (LVAD).\n9. Presence of comorbidities or known risk factors for CA complications that, in the judgment of the electrophysiologist, constitute a contraindication to the procedure for safety reasons.\n10. Active, uncontrolled malignancy and\u002For chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure.\n11. Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months.\n12. Presence of comorbidities or known risk factors for radiotherapy complications that, in the judgment of the radiation oncologist, constitute a contraindication to STAR for safety reasons.\n13. Pregnancy or breastfeeding.\n14. Systemic disease that limits the probability of survival to less than 1 year\n15. Other comorbidities, addictions, or social indications that, in the investigator's opinion, would preclude practical cooperation or otherwise disqualify the patient from participation in the clinical study.\n16. Refusal to participate or lack of written informed consent for study participation.",{"count":194,"type":21},150,[117],"The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).",[198,199,200,201,28,202,203,204],"Ventricular Tachycardia, Monomorphic","Ventricular Tachycardia, Sustained","Ventricular Tachycardia (VT)","Ventricular Tachycardia (V-Tach)","Stereotactic Techniques","Stereotactic Radiation","Cardioverter-Defibrillators, Implantable",[206,207,208,209,210,211],"Ventricular Tachycardia","VT","Stereotactic Arrhythmia Radioablation","STAR","Implanted Cardioverter-Defibrillator","ICD","2025-06-04",{"date":214,"type":34},"2025-06-12",{"date":216,"type":21},"2025-07-01",{"date":218,"type":21},"2028-11-01",{"name":220,"class":41},"Medical University of Silesia",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":42},"100582315","phase-2-chemoimmunotherapy-with-or-without-sbrt-before-surgery-for-locally-advanced-oral-and-oropharyngeal-cancer-100582315","NCT06861712","Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer","Neoadjuvant Chemoimmunotherapy With or Without SBRT Followed by Surgery for Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: A Phase II Randomized Trial","Inclusion Criteria:\n\n1. Oral\u002Foropharyngeal squamous cell carcinoma confirmed by histology and\u002For cytology.\n2. Clinical stage: resectable oral\u002Foropharyngeal squamous cell carcinoma stage III-IVa (AJCC 8th edition)\n3. Age: 18-65 years old.\n4. According to the Eastern Cooperative Oncology Group (ECOG) criteria (performance status score of 0 or 1).\n5. Good organ function:\n\n   A. Hematology: WBC ≥ 4000\u002FμL, neutrophil ≥ 2.000\u002FμL, hemoglobin ≥ 9g\u002FdL, platelet ≥ 100000\u002FμL; B. Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times, and alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3g\u002FdL; C. International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; D. Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60mL\u002Fmin according to the Cockcroft-Gault formula.\n6. Expected survival ≥ 3 months.\n7. The patient has signed an informed consent form and is willing and able to comply with the study visits, treatment plans, laboratory tests and other study procedures.\n8. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose (including chemotherapy drugs and Teplizumab).\n9. If the female partner of the male subject is still of childbearing potential, the male subject must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors.\n2. Patients with known or suspected autoimmune diseases, including dementia and epilepsy.\n3. Patients with severe mental illness.\n4. Patients with necrotic lesions and who are assessed by the researchers to be at risk of major bleeding.\n5. Patients with severe heart disease, pulmonary dysfunction, heart function and pulmonary function below grade 3 (including grade 3).\n6. Patients whose laboratory test values do not meet the relevant standards within 7 days before enrollment.\n7. Patients who have received systemic or local glucocorticoid treatment within 4 weeks before enrollment.\n8. Patients with complications that require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects.\n9. Patients with active pulmonary tuberculosis (TB) who are currently receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.\n10. Previous use of anti-toripalimab, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway).\n11. Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood and no need for any intervention as adults can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included).\n12. HIV positive.\n13. HBsAg positive and HBVDNA copy number positive (quantitative detection ≥1000cps\u002Fml); positive blood screening for chronic hepatitis C (HCV antibody positive).\n14. Any anti-infection vaccine (such as influenza vaccine, varicella vaccine, etc.) received within 4 weeks before enrollment.\n15. Women of childbearing age with positive pregnancy test and breastfeeding women.",{"count":142,"type":21},[24],"In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.",[232,233,28],"Oral Squamous Cell Carcinoma (OSCC)","Oropharyngeal Squamous Cell Carcinoma (SCC)",[232,233,28,235,236],"Toripalimab","Phase II Clinical Trial","2025-04-22",{"date":239,"type":34},"2025-04-25",{"date":241,"type":21},"2025-05-06",{"date":243,"type":21},"2026-12-31",{"name":245,"class":41},"Sun Yat-sen University"]