Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Recruiting Phase 3 Interventional Study
Childhood Extracranial Germ Cell Tumor Extragonadal Embryonal Carcinoma Germ Cell Tumor Malignant Germ Cell Tumor Malignant Ovarian Teratoma Stage I Ovarian Choriocarcinoma Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage I Testicular Choriocarcinoma AJCC v6 and v7 Stage I Testicular Embryonal Carcinoma AJCC v6 and v7 Stage I Testicular Seminoma AJCC v6 and v7 Stage I Testicular Yolk Sac Tumor AJCC v6 and v7 Stage II Ovarian Choriocarcinoma Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage II Testicular Choriocarcinoma AJCC v6 and v7 Stage II Testicular Embryonal Carcinoma AJCC v6 and v7 Stage II Testicular Yolk Sac Tumor AJCC v6 and v7 Stage III Ovarian Choriocarcinoma Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage III Testicular Choriocarcinoma AJCC v6 and v7 Stage III Testicular Embryonal Carcinoma AJCC v6 and v7 Stage III Testicular Yolk Sac Tumor AJCC v6 and v7 Stage IV Ovarian Choriocarcinoma Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7 Testicular Mixed Choriocarcinoma and Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Teratoma Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,780 (estimated)
Sponsor
Children's Oncology Group · Research network
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About This Trial
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\]) * Standard risk 1: Patients must be \< 11 years of age at enrollment * Standard risk 2: Patients must be \>= 11 and \< 25 years o…
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