Overview

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

Status:
Completed

Trial end date:
2015-04-14

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 3

Details

Lead Sponsor:

Eastern Cooperative Oncology Group

Treatments:

Isotretinoin
Tretinoin