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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

NCT03067181

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

Associated Conditions

Brain Cancer

Principal Investigator

Sponsor

Children's Oncology Group

Low Risk Subjects (Age <50 Years): The overall goal is to see if monitoring subjects with low risk germ cell tumors after their tumor is removed is as effective as following surgery with chemotherapy and/or more surgery. Standard Risk 1 Subjects (Age 0 to <11 Years): The overall goal of this study is to compare the effects good and/or bad of carboplatin with cisplatin on people with standard risk germ cell tumors to find out which is better. In this study, you will get either carboplatin or cisplatin. You will not get both. Standard Risk 2 Subjects (Age >11 to <25 Years): The overall goal is to compare the effects good and/or bad of carboplatin with cisplatin on people with standard risk germ cell tumors to find out which is better. In this study, you will get either carboplatin or cisplatin. You will not get both. Adolescent and Young Adult Hearing Screening Study (Age >11 and <25 Years): The overall goal of this study is to learn whether there is a difference in hearing loss for patients treated with cisplatin vs. patients treated with carboplatin. The goal of the questionnaire part of the study is to create a questionnaire that will help us understand patient's own experiences with hearing loss or problems.

This study is currently enrolling.