This phase III trial tests the addition of sodium thiosulfate to standard of care chemotherapy and radiation therapy in treating patients with low or average risk medulloblastoma (a type of cancer in the brain). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects are unintended problems that arise due to treatment such as learning difficulties, lower amounts of hormones, hearing problems, or other problems in performing daily activities. Patients with medulloblastoma often receive treatment with chemotherapy drugs including cisplatin. Cisplatin may cause hearing loss as a side effect. Previous studies with sodium thiosulfate have shown that it may help reduce or prevent hearing loss caused by cisplatin. This study looks at adding sodium thiosulfate to standard treatment for medulloblastoma (radiation therapy and chemotherapy, including cisplatin) to find out if it reduces hearing loss.
ACNS2031: A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features.
3 Years to 21 Years