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
Objective
Primary Aims To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients (ages 0- 50 years) with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. To compare the event-free survival of a carboplatin vs. cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk germ cell tumors. To compare the EFS of a carboplatin-based regimen (CEb) vs. a cisplatin-based regimen (PEb) in children (less than 11 years in age) with standard risk GCT. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - 25 years) with standard risk GCT.
Secondary Aims To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors. To assess the utility of using an established panel of four circulating microRNAs as a universal marker of diagnosis, recurrence and response to therapy. To identify novel genetic variants associated with an increased risk of platinum-associated ototoxicity as determined by standard audiology at the end of therapy using both a candidate gene and genome wide approach.
