[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658138":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":37,"studyPopulation":28,"armGroups":38,"interventions":54,"overallOfficials":28,"centralContacts":82,"locations":88,"responsibleParty":112,"collaborators":114,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":28,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":28,"enrollmentInfo":131,"targetDuration":28,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":91,"whyStopped":28,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Blokhin's Russian Cancer Research Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"1-year progression-free survival (PFS)","1-year PFS is defined as time from enrollment to disease progression or relapse or death due to any cause at 1 year (12-month PFS)","Time from enrollment to disease progression or relapse or death due to any cause, or data cut-off date at 1 year, whichever occured first (up to ~60 months)",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Overall Survival","OS is defined as time from enrollment to death due to any cause","Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months)",{"measure":19,"description":20,"timeFrame":21},"Complete response rate (CRS)","CRS is defined as normalization of tumor markers and no clinical or radiological evidence of disease","Time from enrollment to completion of the 4th cycle of chemotherapy, disease progression, or death, whichever occurs first (up to ~48 months)",{"measure":23,"description":24,"timeFrame":17},"Pathological complete response (pCR)","pCR is defined as normal tumor markers and completely resected residual masses containing only necrosis or teratoma",{"measure":26,"description":27,"timeFrame":17},"Adverse events","Safety per CTCAE v5.0.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":35},"SINGLE",[36],"PARTICIPANT","Screening procedures:\n\n* AFP, b-HCG, LDH - ≤7 days before enrollment;\n* Complete blood counts;\n* Blood chemistry;\n* Urinalysis;\n* Chest, abdominal and pelvic CT-scan with IV enhancement;\n* Electrocardiogram;\n* Brain MRI scan as clinically indicated (neurologic symptoms, post-orchiectomy serum beta-hCG \\> 5000 IU\u002FL or extensive lung metastasis)\n\nTreatment:\n\nAfter registration patients will receive first cycle of standard BEP chemotherapy: cisplatin 20 mg\u002Fm² IV days 1-5, etoposide 100 mg\u002Fm² IV days 1-5, bleomycin 30 mg IV days 1, 8 and 15 OR days 1, 3 and 5 + G-CSF 5 mcg\u002Fkg subcutaneous day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\\^9. In patients with ultra-high level of tumor markers and\u002For poor performance status (eg, ECOG3-4) administration of a disease stabilizing chemotherapy first cycle of chemotherapy is allowed.\n\nAfter 1st cycle of BEP tumor markers will be reassessed between days 18 and 21, and their kinetics will be centrally calculated (App: Tumor marker decline calculator poor-risk GCT - http:\u002F\u002Fwww.gustaveroussy.fr\u002Fcalculation-tumor\u002FNSGCT.html).\n\nPatients with favorable tumor markers for both AFP and B-HCG decline will receive three subsequent cycles of BEP.\n\nPatients with unfavorable tumor markers decline will be centrally randomized stratified by center, mediastinum primary tumor, 1st cycle in stabilizing schedule, and brain metastasis to the following arms.\n\n* three additional cycles of T-BEP: paclitaxel 175 mg\u002Fm2 IV days 1, cisplatin 20 mg\u002Fm² IV days 1-5, etoposide 100 mg\u002Fm² IV days 1-5, bleomycin 30 mg IV days 1, 8 and 15 OR days 1, 3 and 5 + G-CSF 5 mcg\u002Fkg subcutaneous day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\\^9 - cycled every 21 days (experimental arm).\n* Three additional cycles of BEP: cisplatin 20 mg\u002Fm² IV days 1-5, etoposide 100 mg\u002Fm² IV days 1-5, bleomycin 30 mg IV days 1, 8 and 15 OR days 1, 3 and 5 + G-CSF 5 mcg\u002Fkg subcutaneous day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\\^9 (standard arm).\n\nPatients with complete response radiological and marker response after completion of chemotherapy to be followed without additional therapy (surveillance according to guidelines). Patients with radiographically detectable residual masses (eg, retroperitoneal lymph nodes, mediastinal lymph nodes, lung metastases) ≥10 mm and normal STMs (partial remission with negative STMs) should undergo surgery with goal to remove all the residual disease. If the patient considered to have unresectable tumor or to be medically inoperable the treatment approach is to be selected individually.\n\nPatients with viable GCTs in completely resected masses (except for mature teratoma) will be managed with 2 more cycles of EP or TIP chemotherapy.\n\nPatients are following for at least 3 years according to the following schedule: once every 2 months for 2 years, once every 4 months in the third year, once every 6 months in the fourth year, and once every year after the fourth year. Surveillance includes a clinical examination, AFP, b-HCG, LDH, creatinine, blood count, and a CT scan of the initially involved sites every 4 months for 2 years, and then once yearly in the next 3 years.",[39,49],{"label":40,"type":41,"description":42,"interventionNames":43},"T-BEP","EXPERIMENTAL","Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.",[44,45,46,47,48],"Drug: Paclitaxel","Drug: Bleomycin","Drug: Etoposide","Drug: Cisplatin","Drug: G-CSF (Filgrastim)",{"label":50,"type":51,"description":52,"interventionNames":53},"BEP","ACTIVE_COMPARATOR","Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.",[45,46,47,48],[55,60,64,70,74],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":28},"DRUG","Paclitaxel","Paclitaxel 175 mg\u002Fm\\^2 IV infusion, Day 1, Q3W for 3 cycles in first line",[40],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":28},"Bleomycin","Bleomycin sulfate 30 mg IV infusion, Days 1,3,5, Q3W for 4 cycles in first line",[50,40],{"type":56,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Etoposide","Etoposide 100 mg\u002Fm\\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line",[50,40],[69],"VP-16",{"type":56,"name":71,"description":72,"armGroupLabels":73,"otherNames":28},"Cisplatin","Cisplatin 20 mg\u002Fm\\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line",[50,40],{"type":56,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"G-CSF (Filgrastim)","G-CSF 5 mcg\u002Fkg subcutaneous, on Day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\\^9, Q3W for 4 cycles in first line",[50,40],[79,80,81],"Zarzio","Tevagrastim","Neupomax",[83],{"name":84,"role":85,"phone":86,"phoneExt":28,"email":87},"Edgar Israelyan, PhD","CONTACT","+7-919-879-92-54","e.israelyan@yandex.ru",[89],{"facility":90,"status":91,"city":92,"state":28,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"N.N. Blokhin National Medical Research Center of Oncology","RECRUITING","Moscow","115522","Russia","RU",{"type":97,"coordinates":98},"Point",[99,100],37.61781,55.75204,{"lat":100,"lon":99},[103,105,108,110],{"name":84,"role":85,"phone":104,"phoneExt":28,"email":87},"+7-499-324-10-87",{"name":106,"role":85,"phone":104,"phoneExt":28,"email":107},"Alexey Rumyantsev, MD","a.rumyantsev@ronc.ru",{"name":84,"role":109,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"name":106,"role":111,"phone":28,"phoneExt":28,"email":28},"SUB_INVESTIGATOR",{"type":113,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[115,117,119],{"name":116,"class":6},"N.N. Petrov National Medical Research Center of Oncology",{"name":118,"class":6},"National Medical Research Radiological Centre of the Ministry of Health of Russia",{"name":120,"class":121},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV","100658138","phase-2-paclitaxel-bleomycinetoposidecisplatin-vs-bleomycinetoposidecisplatin-in-poor-prognosis-non-seminomatous-germ-cell-tumors-nsgct-and-unfavorable-tumor-marker-decline-randomized-phase-ii-trial-100658138",false,"NCT07847190","Paclitaxel-Bleomycin\u002FEtoposide\u002FCisplatin vs Bleomycin\u002FEtoposide\u002FCisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial","Paclitaxel+BEP (T-BEP) vs BEP in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial","Inclusion Criteria:\n\n* Age ≥16 years;\n* Evidence of NSGCT based on histologic examination or clinical evidence (high serum HCG or AFP levels - in case of clinical emergency due to bulky disease, therapy can be started without pathological confirmation of the disease);\n* Testicular, retroperitoneal, or mediastinal primary site;\n* Disease classified as poor prognosis according to IGCCCG criteria:\n\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* No prior chemotherapy;\n* No concurrent malignancies which may have an impact of anticipated lifespan (ie, malignancies other than basal-cell skin carcinoma, in situ carcinomas, borderline ovarian tumors etc);\n* Adequate renal function: measured or calculated glomerular filtration rate \\> 60 ml\u002Fmin.\n* Absolute baseline granulocyte count ≥0.5\\*10\\^9, platelets ≥100\\*10\\^9, bilirubin ≤1.5 ULN.\n* Unfavorable tumor marker decline after 1st cycle of standard BEP chemotherapy calculated according to time to normalization from the K. Fizazi study in JCO 2004.\n* Signed informed consent before protocol-specific procedures.\n\nExclusion Criteria:\n\n* Primary intracranial germ-cell tumors;\n* Patients with seminomas or dysgerminomas;\n* Patients with normal range of serum tumor markers before starting treatment;\n* Patients with favorable tumor markers decline;\n* Patients infected by the Human Immunodeficiency Virus (HIV);\n* Patients with contraindications to taxane agents (hypersensitivity to paclitaxel);\n* Patients who do not fit inclusion criteria.","MALE","16 Years",{"count":132,"type":133},60,"ESTIMATED","INTERVENTIONAL",[136],"PHASE2","GETUG-13 study has prospectively confirmed poor outcomes in advanced germ cell tumors (GCT) patients with unfavorable decrease of tumor markers after 1 cycle of BEP chemotherapy. There is an unmet medical need to improve outcomes in this subset of patients, however the dose-dense regimen proposed in the above-mentioned trial cannot be implemented in routine clinical practice. T-BEP regimen may have advantage over the traditional BEP regimen as first-line therapy for poor-risk GCT Treatment escalation with T-BEP regimen may be an effective and tolerable therapeutic option for advanced GCT patients with unfavorable tumor markers decline.",[139],"Germ Cell Cancer Metastatic",[141,142,143,144],"testis cancer","germ cell tumor","poor-prognosis non-seminomatous germ cell tumors","unfavorable tumor marker decline","2026-09-23",{"date":147,"type":148},"2026-09-29","ACTUAL",{"date":150,"type":148},"2024-10-01",{"date":152,"type":133},"2029-10",{"name":5,"class":6},1]