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
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|ClinicalTrials.gov Identifier: NCT03370367|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : December 13, 2017
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:
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Stage I-II Head and Neck Cancer||Drug: 13-cis retinoic acid Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Official 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|
|Actual Study Start Date :||February 25, 1991|
|Actual Primary Completion Date :||January 15, 1999|
|Actual Study Completion Date :||April 14, 2015|
Experimental: Arm A
13-cis retinoic acid will be dispensed in 3.75 mg and 5 mg gelatin capsules. Take 2 capsules once a day for up to 2 years.
Drug: 13-cis retinoic acid
Placebo Comparator: Arm B
Take 2 placebo pills once a day for up to 2 years.
- The time to diagnosis of second primary for the treatment versus control groups. [ Time Frame: 20 years ]
- Survival time for the treatment versus control groups. [ Time Frame: 20 years ]