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Type(s) of Cancer
Head and Neck
Study Phase
Phase 3
Study Completion Date
1999-01-15
NCT03370367Uploaded 07-07-2018
Access via NCI by Request
PDS UID: nci-data-377
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 Information
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
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: 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.
ConditionsStage I-II Head and Neck Cancer
Intervention TypeDrug: 13-cis retinoic acid
Other: Placebo
Drug(s)Drug: 13-cis retinoic acid
Total Enrolled189
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm A - Experimental
Arm B - Placebo Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT03370367-D1
Data DictionaryNCT03370367-D1-Data-Dictionary.pdf
DATANCT03370367-D1-Dataset.csv
OTHERREADME.pdf
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