[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548268":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"N.N. Petrov National Medical Research Center of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","In arm patients receive a TI-CE regime based on paclitaxel and ifosfamide in cycles 1-2 and carboplatin and etoposide in cycles 3-5.",[13],"Drug: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )","TI: Paclitaxel 200mg\u002Fm² on day 1, Ifosfamide 2000mg\u002Fm² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms\u002FKg SC daily day on days 6-14 day or until CD34 harvest. Leukapheresis will be performed starting on day 11 in case blood level of CD45+CD34+ above 20x10\\^6\u002FL is achieved.\n\nCE: Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg\u002Fm\\^2 IV daily days -4 to -2, autlologous stemm cell transplantation \\>=2\\*10\\^6\u002FKg at day 0, GCSF support from day 4 until the recovery of neutrophils above 1\\*10\\^9\u002FL.\n\nPatients will receive two cycles of TI followed by 3 cycles of CE in case at least 6\\*10\\^6 CD34+ stem cells will be harvested.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Aleksei M Belyaev, MD,DSc,Prof.","National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia","STUDY_DIRECTOR",{"name":27,"affiliation":24,"role":28},"Tatyana Yu Semiglazova, MD,DSc,Prof.","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Anna Semenova, MD, PhD","CONTACT","8 (812) 439-95-05","mirannia@yandex.ru",[36],{"facility":24,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Saint Petersburg","Russian Federation","197758","Russia","RU",{"type":44,"coordinates":45},"Point",[46,47],30.31413,59.93863,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":20,"phoneExt":20,"email":20},"Anna I Semenova, MD, PhD",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Anna Igorevna Semenova","clinical oncologist","100548268","phase-2-high-dose-chemotherapy-as-second-line-drug-therapy-for-relapsed-germ-cell-tumors-100548268",false,"NCT06418789","High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors","GERMAN","Inclusion Criteria:\n\n1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.\n2. Males ≥ 18 years of age at the time of signing the IC Form.\n3. Histologically verified diagnosis of GO (seminomatous, non-seminomatous).\n\n2\\. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO.\n\n3\\. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP).\n\n4\\. Required Initial Laboratory Values:\n\n* Hemoglobin ≥ 90 g\u002FL;\n* neutrophils ≥ 1.5 x 109\u002FL;\n* platelets ≥ 75 x 109\u002FL;\n* creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL\u002Fmin);\n* ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases);\n* bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol\u002FL);\n* alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presence of CNS metastases (asymptomatic CNS metastases are acceptable).\n\nExclusion Criteria:\n\n1. Primary CS of the brain\n2. Administration of ≥2 lines of prior drug therapy for disseminated GO.\n3. Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion.\n4. Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).","MALE","18 Years",{"count":66,"type":67},25,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors.",[73],"Germ Cell Tumor",[73,75,76,77,78,79,80,81,82,83,84],"Teratoma","Choriocarcinoma","Germinoma","Childhood Teratoma","Extragonadal Seminoma","Seminoma","Non-seminomatous Germ Cell Tumor","Yolk Sac Tumor","Mixed Germ Cell Tumor","Malignant Germ Cell Neoplasm","2025-07-30",{"date":87,"type":88},"2025-08-03","ACTUAL",{"date":90,"type":88},"2024-03-01",{"date":92,"type":67},"2029-03-01",{"name":5,"class":6},1]