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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
Provider Data DescriptionThis dataset contains baseline, efficacy, 13-CRA toxicity, and CTC toxicity data from trial NCT03370367.
SponsorEastern Cooperative Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset189
# of Patients Control94
# of Patients Experimental94
Clinical Trials.gov Information
Brief SummaryIn 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:
The time to diagnosis of second primary for the treatment versus control groups.
Survival time for the treatment versus control groups.
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.