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Clinical Trials

AGCT1531, A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

ClinicalTrials.gov Identifier

NCT03067181

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About This Study

The aim of this study for low and standard risk germ cell tumor (GCT) patients is to minimize toxicity by reducing therapy while maintaining current survival rates. The trial will eliminate chemotherapy for low risk patients who are likely cured with surgery and will observe the salvage rates among those who recur. Low risk patients are defined as Stage I patients, ages 0 50 years old. Since the trial is enrolling patients from pediatric oncology, gynecologic oncology and genito-urinary oncology (testicular cancer) the relevant staging criteria can be found in Appendices II (COG), III (FIGO), IV (AJCC) and V (IGCCC [International Germ Cell Consensus Classification]). The low risk arm will have two strata. One strata will include patients with an ovarian pure immature teratoma: COG Stage I (FIGO Stage IA and IB), Grade 2 or 3 with a maximum alpha fetoprotein ( -FP) of 1,000 ng/mL. The other low risk strata will be comprised of patients with COG Stage I (FIGO Stage IA and B; AJCC Stage IA and B) germ cell tumors at any extracranial site (testes, ovary, extragonadal) that have at least one malignant histology, defined as embryonal carcinoma, choriocarcinoma or yolk sac tumor. Patients with pure seminoma or dysgerminoma are excluded from this trial. Low risk patients who recur may receive treatment, if eligible, on the appropriate standard risk arm. Among standard risk patients the trial will evaluate whether cisplatin, which is the standard-of-care in COG, can be replaced with a less toxic alternative platin analogue, carboplatin. The standard risk arm will be divided into 2 age-based strata: (1) Standard Risk 1 (SR1) arm, which includes patients up to 11 years of age with COG Stage II - IV ovarian, testicular or extragonadal GCT and (2) Standard Risk 2 (SR2) arm, which includes patients between 11 and 25 years of age with COG Stage II III (FIGO Stage IC, II and III) ovarian, COG Stage II extragonadal and testicular, COG Stage II IV with IGCCC good risk disease. SR1 patients will be randomized to receive either 4 cycles of PEb (cisplatin, etoposide and bleomycin) or 4 cycles of CEb (carboplatin, etoposide and bleomycin). SR2 patients will be randomized to receive either 3 cycles of BEP (cisplatin, etoposide and bleomycin) or 3 cycles of BEC (carboplatin, etoposide and bleomycin). Bleomycin will be administered once per cycle for a total of 4 doses in SR1 patients versus weekly for a total of 9 doses in SR2 patients. Several corollary studies, including evaluation of toxicities (including patient-reported outcomes), pharmacogenetic analysis of adverse events, evaluation of a new miRNA diagnostic and prognostic test and molecular pathway analysis of pediatric, adolescent and young adult GCT are important components of this clinical trial.