ACNS2031: A Phase 3 Study of Sodium Thiosulfate for the Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy for Children with Medulloblastoma with Low-Risk Features
ACNS2031
What is the goal of the study?
Medulloblastoma is the most common malignant brain tumor in children. Fortunately, children with medulloblastoma and favorable risk factors experience high rates of survival thus making reduction of treatment toxicity a crucial priority in this patient population. The goal of this study is to reduce cisplatin-induced ototoxicity with sodium thiosulfate (STS) in children (ages 4-21 years) with newly-diagnosed average-risk and low-risk medulloblastoma. This trial will also evaluate the tumor protection potential of STS in a disease-focused setting by monitoring survival against a carefully selected historical control cohort treated identically using the ACNS0331 backbone. Risk stratification will utilize central molecular characterization as well as central histopathological and imaging reviews. Based on historical data showing excellent prognosis, Group 4 patients with chromosome 11 loss who meet clinical criteria will be treated using a reduced craniospinal radiation approach (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy). To longitudinally assess neurocognitive, quality of life, and psychosocial function, this trial will have all eligible subjects complete the COG Standardized Neurocognitive and Behavioral Battery assessments along with patient-reported outcome measures at specific time points. Tissue banking (tumor, blood, and CSF) is incorporated into the research design for future biology studies including comprehensive tumor molecular analysis, circulating tumor DNA, cancer predisposition testing, and pharmacogenomics.
Who can participate in the study?
Please contact the study team listed below to learn more.