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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07419464
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Squamous Cell Carcinoma
  • Recurrent Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-Fluorouracil — DRUG
    Dose modifications or reductions are determined by patient's tolerability to the drug.

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2031

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: 5-Fluorouracil (5-FU) 2D-Q2W
    Patients randomized to Arm 1 will receive 5-FU as a 400mg/m2 bolus followed by 2,400 mg/m2 continuous intravenous infusion (CIVI) over a 46 hour time period every 2 weeks on Day 1-2 and Days 15-16. Each cycle is 28 days.
  • Active Comparator: Arm 2: 5-Fluorouracil (5-FU) 4D-Q3W
    Patients randomized to Arm 2 will receive 5-FU as a 1000g/m2/day continuous intravenous infusion (CIVI) over 4 days every 3 weeks on Day 1-4. Each cycle is 21 days.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Start of treatment through completion of treatment (estimated time up to 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Christine Auberle, MD
[email protected]
314-747-1459
Christine Auberle, MD (PRINCIPAL_INVESTIGATOR)
Douglas Adkins, MD (SUB_INVESTIGATOR)
Brendan Knapp, MD (SUB_INVESTIGATOR)
Peter Oppelt, MD (SUB_INVESTIGATOR)
Jesse Zaretsky, MD, PhD (SUB_INVESTIGATOR)
Esther Lu, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MO

Related Studies