[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-peripheral-nerve-sheath-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-peripheral-nerve-sheath-tumor":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,119],{"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":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100379579","phase-1-metarrestin-ml-246-in-subjects-with-metastatic-solid-tumors-100379579",false,"NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1 (Phase IB only).\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  * Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  --a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  --Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\\*\n\n  ---\\\u003C 1.5x institution upper limit of normal OR\n\n  ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n\n  \\*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight: \\>= 35 kg (\\>= 18 years old) or \\>=40 kg (\\>= 12 and \\\u003C 18 years old).\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease.\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","ALL","12 Years","120 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.",[27,28,29,30,31,32],"Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms",[34,35,36,37,38],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose","RECRUITING","2026-08-15",{"date":42,"type":43},"2026-08-18","ACTUAL",{"date":45,"type":43},"2020-10-27",{"date":47,"type":21},"2028-12-31",{"name":49,"class":50},"National Cancer Institute (NCI)","NIH",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":106,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100534472","phase-1-nrsts2021-a-risk-adapted-study-evaluating-maintenance-pazopanib-limited-margin-dose-escalated-radiation-therapy-and-selinexor-in-non-rhabdomyosarcoma-soft-tissue-sarcoma-nrsts-100534472","NCT06239272","NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)","Inclusion Criteria:\n\nInclusion Criteria - All Patients\n\n* Patients must be 1-30 years at the time of the biopsy that established the diagnosis of NRSTS.\n* Surgical Resection: Patients who had an upfront resection prior to enrollment will be eligible if they are able to begin therapy within 28 days of resection assuming other eligibility criteria are met. Delayed resection is preferred for all patients with intermediate and high-risk disease.\n* Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \\>16 years of age. Note 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\nDiagnosis\n\n• Patients with CIC-DUX 4 rearranged sarcomas will be enrolled on the high-risk stratum only, regardless of presence of metastasis, size, or resection status.\n\nPatient has low-risk disease if the patient has a:\n\n* Low-grade tumor of any size where R0 or R1 surgical margins are anticipated or achieved.\n* High-grade tumors that are \\\u003C 5 cm where R0 or R1 resection margins are anticipated or achieved.\n\nPatient must have adequate organ function in the organs that will be within the radiotherapy field.\n\nAdequate renal function defined as:\n\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2, or\n* A normal serum creatinine based on age\u002Fgender as follows\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.5 1.4\n\nAdequate liver function defined as:\n\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age\n* SGOT (AST) or SGPT (ALT) \\\u003C 2.5 x ULN for age\n\nAdequate cardiac function defined as:\n\n* Ejection fraction of \\> 55% by echocardiogram or cardiac MRI\n* QTc \\\u003C 480 msec\n\nAdequate pulmonary function defined as:\n\n* No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \\> 94% on room air if there is clinical indication for determination.\n\nInclusion Criteria - Intermediate and High Risk Participants\n\nPatient has intermediate-risk if the patient has a:\n\n* Low-grade non-metastatic initially unresectable disease at study enrollment where delayed resection is planned.\n* High-grade \\\u003C 5 cm non-metastatic initially unresectable disease at study enrollment where delayed resection is planned. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is planned are eligible for this arm.\n* High-grade tumor \\> 5 cm that is potentially resectable.\n\nPatient high-risk if the patient has:\n\n* Metastatic disease at presentation\n* Unresectable disease at study enrollment where delayed resection is not anticipated. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is not-planned are eligible for this arm.\n* CIC-DUX4 rearranged sarcoma\n\nOrgan Function\n\nAdequate bone marrow function defined as:\n\n* Absolute neutrophil count \\> 1000\u002FµL\n* Platelet count \\> 100,000\u002FµL\n* Hemoglobin \\> 8 g\u002FdL for patients \\\u003C 16 years of age\n* Hemoglobin \\> 9 g\u002FdL for patients \\> 16 years of age\n\nNote: No transfusions are permitted 7 days prior to laboratory studies to determine eligibility.\n\nAdequate renal function defined as:\n\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2, or\n* A normal serum creatinine based on age\u002Fgender as follows\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.5 1.4\n\nAdequate liver function defined as:\n\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age\n* SGOT (AST) or SGPT (ALT) \\\u003C 2.5 x ULN for age\n\nAdequate cardiac function defined as:\n\n* Ejection fraction of \\> 55% by echocardiogram or cardiac MRI\n* QTc \\\u003C 480 msec\n\nAdequate pulmonary function defined as:\n\n* No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \\> 94% on room air if there is clinical indication for determination.\n\nAnticoagulation\n\nPatients on low molecular weight heparin, warfarin (with a stable INR), or direct oral anticoagulants (DOAC) who have been on a stable dose of are eligible. Patients being treated for a pulmonary embolism or deep venous thrombosis (DVT) must have been treated for a minimum of 6 weeks prior to starting therapy treatment.\n\nLife Expectancy\n\nPatient must have a life expectancy of at least 3 months with appropriate therapy.\n\nExclusion Criteria:\n\n* Patients with known primary CNS sarcoma or CNS metastases are not eligible. Note: Brain imaging is not an eligibility requirement. Tumors with intracranial extension will be allowed.\n* Patients with the following histologic diagnosis are not eligible: intermediate locally aggressive tumors as defined by WHO, malignant rhabdoid tumor, alveolar soft part sarcoma, infantile fibrosarcoma, unresectable\u002Fmetastatic dermatofibrosarcoma protuberans, inflammatory myofibroblastic tumor, desmoid fibromatosis, rhabdomyosarcoma, desmoplastic small round cell tumor, BCOR-CCNB3 fusion positive sarcoma.\n* Bleeding diathesis: Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: Patients aged \\> 17 years with excess of 2.5 mL of hemoptysis are not eligible).\n* Uncontrolled hypertension: Patients with uncontrolled hypertension (CTCAE v5 Grade ≥ 2) are ineligible. Hypertension must be well controlled on stable doses of medication for at least two weeks.\n\nPrior Therapy\n\n* Patients must have had no prior systemic therapy for the treatment of the NRSTS\n* Patients must have had no prior anthracycline or ifosfamide chemotherapy\n* Patients must have had no prior use of pazopanib or similar multi-targeted TKI.\n\nPatients must have had no prior radiotherapy to tumor-involved sites.\n\nNote: Patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded.\n\n* CYP3A4 Substrates WITH Narrow Therapeutic Indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible. Note: the use of fentanyl is permitted.\n* CYP3A4 Inhibitors: Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin, many NNRTIs, diltiazem, verapamil, and grapefruit juice are not eligible.\n* CYP3A4 Inducers: Patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids).\n* Certain medications that are associated with a risk for QTc prolongation and\u002For Torsade's de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible.\n* Subjects with any condition that may impair the ability to absorb oral medications\u002Finvestigational product including:\n\n  * prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel\n  * active peptic ulcer disease\n  * malabsorption syndrome\n\n3.4.12 Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment.\n\n3.4.13 Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\n\n* active peptic ulcer disease\n* known intraluminal metastatic lesions\n* inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation\n* history of abdominal fistula, gastrointestinal perforation or intra- abdominal abscess within 28 days prior to beginning study treatment.\n\n3.4.14 Pulmonary embolism or DVT. Patients must not have experienced:\n\n* An untreated pulmonary embolism or DVT in last 6 months or\n* treated pulmonary embolism or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\n* arterial thrombosis in last 12 months\n\nHistory of serious or non-healing wound, ulcer, or bone fracture.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nHIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n\nPatients who are receiving any other investigational agent(s).\n\nPregnancy and Breast Feeding\n\n* Pregnancy and Breast Feeding Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment.\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.\n* Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential.","30 Years",{"count":60,"type":21},139,[24,62],"PHASE2","The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS).\n\nPrimary Objectives\n\nIntermediate-Risk\n\n* To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT.\n* To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics.\n\nHigh-Risk\n\n* To estimate the maximum tolerated dose (MTD) and\u002For the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants.\n* To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics.\n\nSecondary Objectives\n\n* To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol.\n* To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants.\n* To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity.\n* To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib.\n* To assess the relationship between the pharmacogenetic variation in drug-metabolizing enzymes or drug transporters and the pharmacokinetics of selinexor, pazopanib, and doxorubicin in intermediate- or high-risk patients.\n\nExploratory Objectives\n\n* To explore the correlation between radiographic response, pathologic response, survival, and toxicity, and tumor molecular characteristics, as assessed through next-generation sequencing (NGS), including whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing (RNAseq).\n* To explore the feasibility of determining DNA mutational signatures and homologous repair deficiency status in primary tumor samples and to explore the correlation between these molecular findings and the radiographic response, survival, and toxicity of patients treated on this protocol.\n* To explore the feasibility of obtaining DNA methylation profiling on pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to assess the correlation with this and pathologic diagnosis, tumor control, and survival outcomes where feasible.\n* To explore the feasibility of obtaining high resolution single-cell RNA sequencing of pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to characterize the longitudinal changes in tumor heterogeneity and tumor microenvironment.\n* To explore the feasibility of identifying characteristic alterations in non-rhabdomyosarcoma soft tissue sarcoma in cell-free DNA (cfDNA) in blood as a non-invasive method of detecting and tracking changes during therapy, and to assess the correlation of cfDNA and mutations in tumor samples.\n* To describe cardiovascular and musculoskeletal health, cardiopulmonary fitness among children and young adults with NRSTS treated on this protocol.\n* To investigate the potential prognostic value of serum cardiac biomarkers (high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro B-type natriuretic peptide (NT-Pro-BNP), serial electrocardiograms (EKGs), and serial echocardiograms in patients receiving ifosfamide, doxorubicin, and pazopanib, with or without selinexor.\n* To define the rates of near-complete pathologic response (\\>90% necrosis) and change in FDG PET maximum standard uptake value (SUVmax) from baseline to week 13 in intermediate risk patients with initially unresectable tumors treated with induction pazopanib, ifosfamide, and doxorubicin, and to correlate this change with tumor control and survival outcomes.\n* To determine the number of high-risk patients initially judged unresectable at diagnosis that are able to undergo primary tumor resection after treatment with ifosfamide, doxorubicin, selinexor, and pazopanib.\n* To identify the frequency with which assessment of volumes of interest (VOIs) of target lesions would alter RECIST response assessment compared with standard linear measurements.",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,31,93,94,95,96,97,98,99,100,101,102,103,104,105],"Adipocytic Neoplasm","Liposarcoma","Atypical Fibroxanthoma","Angiomatoid Fibrous Histiocytoma","Fibrosarcoma NOS","Myxofibrosarcoma","Angiosarcoma","Osteosarcoma, Extraskeletal","Dedifferentiated Liposarcoma","Myxoid Liposarcoma","Pleomorphic Liposarcoma","Myxoid Pleomorphic Liposarcoma","Low Grade Fibromyxoid Sarcoma","Sclerosing Epithelioid Fibrosarcoma","Malignant Tenosynovial Giant Cell Tumor of Soft Tissue","Epithelioid Hemangioendothelioma","Glomus Tumor","Inflammatory Leiomyosarcoma","Leiomyosarcoma","Ossifying Fibromyxoid Tumor, Malignant","Myoepithelioma","Synovial Sarcoma","Epithelioid Sarcoma","Perineurioma, Malignant","Clear Cell Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Granular Cell Tumor, Malignant","Melanotic Malignant Nerve Sheath Tumor","Perivascular Epithelioid Tumor, Malignant","Intimal Sarcoma","Myoepithelial Carcinoma","Undifferentiated Sarcoma","Pleomorphic Sarcoma, Undifferentiated","Round Cell Sarcoma, Undifferentiated","NTRK-Rearranged Spindle Cell Neoplasm","Phosphaturic Mesenchymal Tumor, Malignant","Round Cell Sarcoma","Well Differentiated Liposarcoma","Giant Cell Tumor of Soft Parts NOS","Low Grade Myofibroblastic Sarcoma","Dermatofibrosarcoma Protuberans, Fibrosarcomatous",[107],"Proton therapy","2026-07-31",{"date":110,"type":43},"2026-08-03",{"date":112,"type":43},"2024-03-27",{"date":114,"type":21},"2037-06",{"name":116,"class":117},"St. Jude Children's Research Hospital","OTHER",7,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\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* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":129,"type":21},1582,[131],"NA","This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[134,135,136,137,71,138,73,139,90,140,141,83,31,70,75,142,143,144,145,146,147,86,148],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Alveolar Soft Part Sarcoma","Clear Cell Sarcoma of Soft Tissue","Extraskeletal Ewing Sarcoma","Fibrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Sarcoma","Soft Tissue Sarcoma","Soft Tissue Sarcoma of the Trunk and Extremities","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Undifferentiated Pleomorphic Sarcoma","NOT_YET_RECRUITING","2024-07-24",{"date":152,"type":43},"2024-07-30",{"date":154,"type":21},"2025-01-28",{"date":156,"type":21},"2032-11-01",{"name":158,"class":159},"ECOG-ACRIN Cancer Research Group","NETWORK"]