[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-seminomatous-germ-cell-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-seminomatous-germ-cell-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100424216","phase-2-maintenance-oral-etoposide-or-observation-following-high-dose-chemo-for-gct-100424216",false,"NCT04804007","Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT","Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information\n2. Age ≥ 18 years at the time of consent\n3. Histological or serological evidence of non-seminomatous GCT\n4. Relapsed disease after first-line cisplatin-based combination chemotherapy\n5. Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines\n6. HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP \\[vinblastine+ifosfmaide+cisplatin\\] or TIP \\[paclitaxel+ifosfamide+cisplatin\\] or PVB \\[cisplatin+vinblastine+bleomycin\\]\n7. Normal or declining tumor markers (AFP and hCG) at time of screening\n8. Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration\n9. Women with ovarian germ cell tumors are eligible\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days of study registration\n11. Last dose of HDCT must be ≤16 weeks from study registration\n12. Adequate organ function lab values obtained within 28 days prior to study registration System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,000 \u002FmcL Platelets ≥100,000 \u002F mcL Hemoglobin ≥8 g\u002FdL Renal Serum creatinine \\\u003C2mg\u002FdL Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n\n    AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR\n    * 5 X ULN for subjects with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n13. If a female of childbearing potential, a negative urine pregnancy test within 28 days prior to receiving the first dose of study drug.\n\n    o Non-childbearing potential is defined as (by other than medical reasons):\n    * ≥ 45 years of age and has not had menses for \\>2 years\n    * Amenorrheic for \\\u003C 2 years without a hysterectomy and\u002For oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation\n    * Post hysterectomy or oophorectomy. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound.\n14. For female patients of childbearing potential and male patients, agreement (by patient and\u002For partner) to use two forms of highly effective contraception (i.e., one that results in a low failure rate \\[\\\u003C 1% per year\\] when used consistently and correctly) starting with the first dose of study therapy and to continue its use for 30 days after the last dose of study therapy, or abstain from heterosexual activity.\n\nExclusion Criteria:\n\n1. Relapsed pure seminoma\n2. Rising tumor markers (AFP and hCG) at time of screening\n3. Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \\>16 weeks ago\n4. Treatment with any investigational agent within 28 days prior to study registration\n5. Other active malignancy requiring treatment in past 12 months\n6. History of psychiatric illness or social situations that would limit compliance with study requirements\n7. Active infection requiring systemic therapy\n8. Previous hypersensitivity to etoposide which did not recover with supportive care\n9. Pregnancy, lactation, or breastfeeding\n10. 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.","ALL","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).",[26,27,28],"Germ Cell Tumor","Non-seminomatous Germ Cell Tumor","Ovarian Germ Cell Tumor",[26],"RECRUITING","2026-05-05",{"date":33,"type":34},"2026-05-08","ACTUAL",{"date":36,"type":34},"2021-03-03",{"date":38,"type":20},"2028-12",{"name":40,"class":41},"Nabil Adra","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100493479","validation-of-a-treatment-algorithm-for-poor-risk-nsgctnon-seminomatous-germ-cell-tumors-100493479","NCT05705687","Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors","A Prospective Program Aiming at Improving Outcome for Young Adults With Poor-prognosis","VAPOR","Inclusion Criteria:\n\n* Male patient older than 16 years old on day of signing informed consent\n* Patient with evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum hCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated)\n* Patient with testicular, retroperitoneal, or mediastinal primary site\n* Patient with evidence of disseminated disease (clinical stages II or III according to AJCC 8th edition)\n* Patient with disease classified as poor prognosis according to IGCCCG criteria:\n* Primary mediastinal NSGCT or,\n* Non-pulmonary visceral metastases or,\n* hCG \\> 50 000 UI\u002FL, or AFP \\> 10 000 ng\u002FmL, or LDH \\> 10 times the upper normal value\n* Patient with adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance \\> 60 mL\u002Fmin. Cockcroft formula: CrCl = \\[(140-age) x weight in kg\\]\u002F\\[72 x serum creatinine (mg\u002FdL)\\]\n* Patient with absolute granulocyte count \\> or = 1,500\u002Fmm\\^3, platelets \\> or = 100,000 mm\\^3, bilirubin \\\u003C or = 1.5x the upper limit of normal value.\n* Patient with a contra-indication of undergoing any brain MRI are eligible, but will not be part of the diagnostic study part\n* Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the informed consent form\n* Patient affiliated to social security system or beneficiary of the same\n* Male of child-bearing potential, must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\n\nInclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle)\n\n* Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the specific Phase II informed consent form\n* Patient with mediastinal primary site\n* Patient with unfavorable serum marker decrease evaluated at D18-D21 of the first BEP-chemotherapy\n\nExclusion Criteria:\n\n* Patient infected by the Human Immunodeficiency Virus (HIV)\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n* Patient with prior chemotherapy. Patients who have received a first cycle of cisplatin-base chemotherapy (BEP) for their poor-prognosis NSGCT are eligible as far as tumor marker decline can be assessed at day 18-21.\n* Patient with previous malignancy, except for basal-cell carcinoma of the skin\n* Known allergy or hypersensitivity to any of the study drugs\n\nNon inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle)\n\n* Patient (and his legal guardian for under-18 patient) who withdraws his consent\n* Patient with Human T-cell Leukemia Virus (HTLV) type 1 and 2\n* Patient with Hepatitis B surface antigen\n* Patient with Hepatitis C antibody\n* Patient with prior high-dose chemotherapy (HDCT) plus hematopoietic stem cell HSCs transplant","MALE","16 Years",{"count":54,"type":20},150,[56],"NA","This is a prospective multicenter, non-randomized research program that includes:\n\n* a phase IV study (for all patients) with a collection of tissue specimens of tumor,\n* a phase II study (for patients with primary mediastinal tumors and an unfavorable decline in tumor markers),\n* and a diagnostic study (for all patients, except patients with brain metastases at baseline or patients for whom any brain MRI is contra-indicated).\n\nThe main question it aims to answer is improving outcome for young adults with poor-prognosis Non Seminomatous Germ Cell Tumor (NSGCT) is to validate prospectively the efficacy and safety of a personalized treatment based on early tumor marker kinetic assessment in real life for patients with poor-prognosis NSGCT.\n\nParticipants will be followed-up according to the assessment of decline kinetics of the tumor markers at the end of a first chemotherapy cycle and according to the localisation of the primary lesion if unfavorable.\n\n* In the case of a patient with a favorable decline of the tumor markers, he will be treated by 3 additional standard chemotherapy cycles.\n* In the case of a patient with a testicular or peritoneal primary tumor and an unfavorable decline of the tumor markers, the patient will be treated by a dose-dense standard therapy.\n* The patient with a mediastinal primary tumor and an unfavorable decline of the tumor markers will be proposed to enter the phase II part of the study or to enter the dose-dense regimen like the other primary localisations. If the patient consents and is eligible for phase II part, he will undergo either an early surgery if feasible or a high-dose chemotherapy if the early surgery is not possible.",[59],"Non-Seminomatous Germ Cell Tumor","2025-05-07",{"date":62,"type":34},"2025-05-08",{"date":64,"type":34},"2023-05-05",{"date":66,"type":20},"2037-02",{"name":68,"class":41},"Gustave Roussy, Cancer Campus, Grand Paris"]