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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Central Nervous System, Germ, Ovarian, Bone Sarcoma, Neuroblastoma, Liver, and Brain

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

Unique Dataset IDnci-data-13ClinicalTrial.gov IDNCT00716976
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients131RandomizationYesPubMed (PMID)27914822.0
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeDrug, PlaceboDataset TypeOther

NCI Description

NCT00716976-D2 These data provide the incidence of toxicities. There is one record per patient-cycle. analysiset2=1 for rows included in Table 3 construction. analysiset3=1 for rows included in Table 4 construction.

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study Objectives

Primary: To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy. Secondary: To compare the mean change in hearing thresholds for key frequencies in these patients. To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients. To compare the event-free survival and overall survival of these patients. To evaluate the association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss in these patients.

Outcome Measures

Primary: Incidence of Hearing Loss [ Time Frame: 4 weeks after last dose of cisplatin ] Secondary: Change in Hearing Thresholds For Key Frequencies at 500 hz [ Time Frame: 4 weeks after last dose of cisplatin ] Change in Hearing Thresholds For Key Frequencies at 1000 hz [ Time Frame: 4 weeks after last dose of cisplatin ] Change in Hearing Thresholds For Key Frequencies at 2000 hz [ Time Frame: 4 weeks after last dose of cisplatin ] Change in Hearing Thresholds For Key Frequencies at 4000 hz [ Time Frame: 4 weeks after last dose of cisplatin ] Change in Hearing Thresholds For Key Frequencies at 8000 hz [ Time Frame: 4 weeks after last dose of cisplatin ] Event-Free Survival (EFS) [ Time Frame: 4 years after enrollment ] Overall Survival (OS) [ Time Frame: 4 Years after enrollment ] Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT) [ Time Frame: 4 weeks after the last dose of cisplatin ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00716976-D2-Data-Dictionary.pdf

DATA: NCT00716976-D2-Dataset.csv

OTHER: README.pdf