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Type(s) of Cancer
CNS, Germ Cell, Head and Neck, Liver, Neuroblastoma, Ototoxicity, Ovarian, Sarcoma
Study Phase
Phase 3
Study Completion Date
April 2015
NCT00716976Uploaded 06-07-2017
Access via NCI by Request
PDS UID: nci-data-357
A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
Provider Information
Provider Data DescriptionNCT00716976-D3 One row for each of the 194 serious adverse events detailed on manuscript page 69. These events are reported through the National Cancer Institute, Cancer Therapy Evaluation Program, Adverse Event Reporting System (CTEP-AERS).
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBrain Tumor
Central Nervous System Tumor
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Liver Cancer
Neuroblastoma
Ototoxicity
Ovarian Cancer
Sarcoma
Intervention TypeDrug: sodium thiosulfate
Procedure: examination
Drug(s)Drug: sodium thiosulfate
Total Enrolled131
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionSTS Arm (sodium thiosulfate treatment) - Experimental
Observation Arm (No sodium thiosulfate treatment) - Experimental
Secondary IDCOG-ACCL0431
PubMed (PMID)27914822
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Age Range1 Year to 18 Years (Child, Adult)
Files: NCT00716976-D3
Data DictionaryNCT00716976-D3-Data-Dictionary.pdf
DATANCT00716976-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00716976-D2
Data DictionaryNCT00716976-D2-Data-Dictionary.pdf
DATANCT00716976-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00716976-D1
Data DictionaryNCT00716976-D1-Data-Dictionary.pdf
DATANCT00716976-D1-Dataset.csv
OTHERREADME.pdf
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