Phase 3 Study of Sodium Thiosulfate to Reduce Hearing Loss in Children With Average-Risk Medulloblastoma and Reduced Radiation Therapy in Children With Low-Risk Medulloblastoma

What this Trial Is About

Researchers are evaluating treatments for children and young adults with low-risk and average-risk medulloblastoma, a type of brain cancer. This phase III trial aims to reduce hearing loss caused by cisplatin chemotherapy in average-risk patients by adding sodium thiosulfate STS to standard treatment. For low-risk patients, the study tests whether reduced radiation therapy can maintain benefits while causing fewer side effects. The study also monitors survival, tumor recurrence, and quality of life outcomes. Participants receive radiation therapy five days a week for six weeks, alongside weekly vincristine infusions during this period. Following chemoradiotherapy, maintenance therapy includes cycles of lomustine, cisplatin, sodium thiosulfate, cyclophosphamide, and vincristine given on specific days over up to nine cycles, depending on tolerance and disease progression. Patients undergo regular MRI scans and may provide cerebrospinal fluid and blood samples during the study. Throughout the trial, participants are closely monitored with hearing tests, neurocognitive assessments, and quality-of-life surveys. Follow-up visits occur every three months for the first two years, every six months for years three and four, and annually up to ten years to track hearing loss, event-free survival, overall survival, tumor recurrence, and psychosocial outcomes. The study also collects biological samples for future molecular research, with the total participation lasting up to ten years.

A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss