CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
sodium thiosulfate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00716976
NCT00716976Phase 3Completed
CompareCT.gov

A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Children's Oncology Group·interventional·Posted Jul 16, 2008·Updated Nov 9, 2023

In Brief

A Phase 3 clinical trial evaluating sodium thiosulfate and examination for Brain Tumor and 8 related conditions. Completed, enrolled 131 participants across 76 sites in 3 countries.

Detailed Summary

RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Tumor, Central Nervous System Tumor, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Liver Cancer, Neuroblastoma, Ototoxicity, Ovarian Cancer, Sarcoma
CountriesAustralia, Canada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2008
Enrollment StartJun 23, 2008
Primary CompletionApr 9, 2015
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.0 years ago

Interventions

sodium thiosulfatedrug

Given IV

examinationprocedure

Patients undergo audiological assessments periodically