Actively Recruiting
5-Fluorouracil Response and Optimization STudy (The FROST Trial)
Led by Washington University School of Medicine · Updated on 2026-04-27
46
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Joseph Sanchez Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
5-Fluorouracil Response and Optimization STudy (The FROST Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC) of the oral cavity, oropharynx, larynx, hypopharynx, p16+ level 2-3 neck node with unknown primary, or second primary HNSCC in a previously radiated field not suitable for curative surgery or re-radiation
- Measurable disease according to RECIST 1.1 criteria
- Previously treated with platinum-based chemotherapy with RM disease within 6 months of definitive cisplatin + radiation therapy or post-operative adjuvant cisplatin + radiation therapy, or progressive disease on/after or intolerance to platinum for RM disease
- Previously treated with PD-1 inhibitor with RM disease within 6 months of PD-1 inhibitor as part of curative therapy, or progressive disease on/after PD-1 inhibitor for RM disease, or intolerance to prior PD-1 inhibitor
- At least 18 years of age
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow and organ function, including absolute neutrophil count ≥ 1.0 K/cumm, platelets ≥ 100 K/cumm, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) or ≤ 3 x IULN for Gilbert's disease, AST/ALT/ALP ≤ 3 x IULN (ALP ≤ 5 x IULN if bone metastasis), serum creatinine < 3 mg/dL or creatinine clearance > 30 mL/min
- Agreement to use adequate contraception for women of childbearing potential and men prior to and during study, and for 30 days after last dose of 5-FU
- Recovery to baseline or ≤ grade 1 from adverse events due to prior therapy, except for clinically insignificant or stable controlled toxicities
- Ability to understand and willingness to sign informed consent or have legally authorized representative consent
You will not qualify if you...
- Prior treatment with 5-Fluorouracil for recurrent or metastatic head and neck squamous cell carcinoma
- Prior or concurrent malignancy that could interfere with safety or efficacy assessments, except malignancies without such potential
- Currently receiving other investigational agents
- Recurrent or incurable second primary squamous cell carcinoma of cutaneous, nasopharynx, paranasal, nasal, or sinus origin
- Deficiency in DPYD enzyme (poor or intermediate metabolizer) confirmed by genetic testing
- Severe liver impairment (Child-Pugh C) or history of hepatitis B or C
- Untreated brain metastases; treated brain metastases allowed if imaging shows no progression
- History of allergic reactions to 5-FU or similar compounds
- Pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test within 14 days prior to registration
- HIV infection without effective anti-retroviral therapy and undetectable viral load for at least 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
C
Christine Auberle, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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