Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Alert icon

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:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
  2. After adding all desired datasets to your request, you must complete a request form accessible via the 'My Data Requests' link in your account profile. After submitting your data request form, your request will be delivered to NCI for approval.
  3. Once your request is approved, you will receive notice that you have access to the dataset(s) in SAS® Life Sciences Analytic Framework within the Project Data Sphere Cancer Research Platform and that you may download the dataset(s) onto a personal machine.

To be able to request access to this data and the other analytic tools click here.

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

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

Unique Data Set IDnci-data-14
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNCITotal Study Enrolled Patients131RandomizationYesPubMed (PMID)27914822.00ClinicalTrial.gov IDNCT00716976ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00716976
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypePlacebo, DrugData Set TypeOther

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-D1-Data-Dictionary.pdf

DATA: NCT00716976-D1-Dataset.csv

OTHER: README.pdf