Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

The purpose of this study is to find out whether some people with germ cell tumors can be treated with fewer side effects. For people with low-risk tumors, the study will look at whether close monitoring after surgery works as well as giving chemotherapy and/or more surgery. Chemotherapy or more surgery would only be given if the cancer comes back. For people with standard-risk tumors, the study will look at whether replacing the chemotherapy drug cisplatin with a similar drug called carboplatin works just as well and causes fewer side effects.

• Children and Adults 0+ years of age
• Confirmed diagnosis of Stage I germ cell tumor for low-risk tumor
• Confirmed diagnosis of Stage II or higher germ cell tumor for standard-risk tumor

• Close monitoring after surgery, with no chemotherapy unless the cancer comes back for patients with lower-risk tumors
• Random assignment to bleomycin and etoposide with either carboplatin or cisplatin, chemotherapy medicines given intravenously (IV), for patients with standard-risk tumors
• Radiation therapy and/or surgery per standard of care treatment if determined by the doctor
• Computed tomography (CT), magnetic resonance imaging (MRI), and/or chest x-rays to monitor disease progression
• Blood samples, with possible tumor biopsy
• Lung function test