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

This randomized phase II trial will characterize the efficacy, adverse event (AE) profile, and safety of two regimens of 5-FU given as 2L+ treatment to patients with RM-HNSCC. Eligible patients for this trial will have previously received platinum and PD-1 inhibitor therapy. The experimental regimen (Arm 1) will comprise the two days every two weeks (2D-Q2W) regimen of 5-FU. The standard regimen (Arm 2) will consist of the four days every three weeks (4D-Q3W) regimen of 5-FU. The primary hypotheses is that each regimen of 5-FU will result in an ORR of 10% of greater assessed by RECIST v1.1 criteria. The study will also describe treatment-related AEs assessed by CTCAE v5.0, dose interruptions, discontinuations, and modifications in each regimen.

NCT Number	NCT07419464
Lead Sponsor	Washington University School of Medicine Collaborators: The Joseph Sanchez Foundation
Conditions	Squamous Cell Carcinoma of Head and Neck, Metastatic Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck
Enrollment	46 participants
Start Date	2026-04-21
Primary Completion	2028-07-31 (estimated)
Study Completion	2031-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-27