Phase II Trial Comparing Two 5-Fluorouracil Dosing Schedules for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Previously Treated With Platinum and PD-1 Inhibitors

What this Trial Is About

Researchers are evaluating two different dosing schedules of the drug 5-Fluorouracil 5-FU as second-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma RM-HNSCC who have already received platinum and PD-1 inhibitor therapies. This phase II trial aims to assess the effectiveness, safety, and side effects of these two regimens. The main goal is to see if either regimen achieves a tumor response rate of at least 10%, measured by standardized criteria. Participants will be randomly assigned to one of two treatment groups. Arm 1 receives 5-FU as a 400 mgm2 bolus followed by a continuous intravenous infusion of 2,400 mgm2 over 46 hours every two weeks, with each cycle lasting 28 days. Arm 2 receives 5-FU as a continuous intravenous infusion of 1,000 mgm2 per day over four days every three weeks, with each cycle lasting 21 days. Dose adjustments may be made based on patient tolerance. Throughout the treatment period, which may last up to four months, participants will be monitored for tumor response, side effects, and treatment interruptions or discontinuations. Researchers will evaluate treatment-related adverse events, dose intensity, and survival outcomes over up to three years and four months following treatment completion. Safety assessments continue for 28 days after treatment ends, ensuring comprehensive monitoring of participants health and response to therapy.

5-Fluorouracil Response and Optimization STudy (The FROST Trial)