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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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Head-Neck

Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer

Unique Dataset IDnci-data-54
DownloadableNo
SponsorEastern Cooperative Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients189RandomizationYesPubMed (PMID)28786105.00ClinicalTrial.gov IDNCT03370367ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT03370367
Study PhaseClinical Study Phase IIIBlinding MethodSingle-BlindedType(s) of dataN/AIntervention TypeDrug, PlaceboDataset TypeOther

NCI Description

This dataset contains baseline, efficacy, 13-CRA toxicity, and CTC toxicity data from trial NCT03370367.

Clinical Trial Title

Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer

Trial Summary and Conditions

In this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high probability of cure from their primary cancer. Comparisons between patients treated by 13-cRA and patients receiving placebo will include: 1. The time to diagnosis of second primary for the treatment versus control groups. 2. Survival time for the treatment versus control groups. 3. Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.

Data Summary

See data dictionary for more details.

Study Objectives

Not Provided.

Outcome Measures

Primary: The time to diagnosis of second primary for the treatment versus control groups. [ Time Frame: 20 years ] Secondary: Survival time for the treatment versus control groups. [ Time Frame: 20 years ]

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: NCT03370367-D1-Data-Dictionary_1.pdf

DATA: NCT03370367-D1-Dataset_1.csv

OTHER: README.pdf