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
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05382338?term=NCT05382338&viewType=Table&rank=1#participation-criteria
Summary
Primary Outcome Measures:
1. Percentage of patients with >= grade 2 hearing loss [ Time Frame: At 4 weeks after the last dose of cisplatin ]
2. Event-free survival (EFS) [ Time Frame: From initiation of the protocol treatment to the occurrence of disease
progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up
to 10 years ]
Secondary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Up to 10 years ]
2. Incidence of ototoxicity-related cisplatin dose modifications in the average-risk cohort [ Time Frame: Up to 10
years ]
3. Incidence of cisplatin-related nephrotoxicity in both the average-risk and low-risk cohorts [ Time Frame: Up to 10
years ]
4. Full scale intelligence neurocognitive outcomes and trajectories of patients with average-risk medulloblastoma
treated with sodium thiosulfate (STS) [ Time Frame: Up to 5 years ]
5. Quality of life and psychosocial outcomes of patients with average-risk medulloblastoma treated with STS [ Time
Frame: Up to 5 years ]
6. EFS in patients with low-risk features treated using a reduced craniospinal radiation approach [ Time Frame: Up to
10 years ]
7. OS in patients with low-risk features treated using a reduced craniospinal radiation approach [ Time Frame: Up to
10 years ]
8. Trajectory of hearing loss medulloblastoma patients treated with STS [ Time Frame: Up to 60 months ]
9. Household material hardship as a social determinant of neurocognitive, quality of life, and psychosocial outcomes
in patients with average-risk and low-risk medulloblastoma [ Time Frame: Up to 60 months post-enrollment ]