NCT03370367

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Stage I-II Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	13-cis retinoic acid	Taken daily.
OTHER	Placebo	Placebo

Timeline

• Start date: 1989-05-15
• Primary completion: 1999-01-15
• Completion: 2015-04-14
• First posted: 2017-12-12
• Last updated: 2023-06-15

Regulatory

• FDA-regulated drug study