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 cri

Trial Details

NCT ID
NCT07419464
Phase
PHASE2
Sponsor
Washington University School of Medicine
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • 5-Fluorouracil
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Histologically or cytologically confirmed:
  • RM-HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx, OR
  • p16+ (HPV-related) level 2-3 neck node and unknown primary site, OR
  • Second primary HNSCC in a previously radiated field not amenable to curative-intent surgery and/or re-radiation.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Head and Neck Cancer Trials on Trialify →