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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.

To evaluate the efficacy of sodium thiosulfate (STS) infusion administered during cisplatin-containing chemotherapy cycles (compared to a historical cohort selected from ACNS0331 which received chemotherapy without STS) in reducing hearing loss in children with newly-diagnosed average-risk medulloblastoma.
AND
To estimate and monitor event-free survival (EFS) in this study against a carefully selected cohort from ACNS0331 to guard against loss of efficacy due to STS.

Protocol Number: 112509
Phase: Phase III
Applicable Disease Sites: Brain and Nervous System
Principal Investigator: Nehal Parikh
Scope: National
Participating Institutions:
  • RWJBarnabas Health
    • Newark Beth Israel Medical Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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