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5-Fluorouracil Response and Optimization STudy (The FROST Trial) | Clinical Trials | Clareo Health

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

The 5-Fluorouracil Response and Optimization STudy (The FROST Trial): A Randomized Phase II Trial of Two Dosage Regimens (2D-Q2W vs 4D-Q3W) of 5-Fluorouracil (5-FU) in Patients With Platinum and PD-1 Inhibitor Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT07419464•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.
•Measurable disease per RECIST 1.1.
•Previously treated with platinum-based chemotherapy, RM disease within 6 months of definitive cisplatin + radiation therapy (DCisRT) or post-operative adjuvant cisplatin + radiation therapy (POACisRT) OR progressive disease on or after or intolerance to platinum agent given for RM disease.
•Previously treated with PD-1 inhibitor, RM disease within 6 months of PD-1 inhibitor given as part of curative-intent therapy OR progressive disease on or after PD-1 inhibitor given for RM disease OR intolerance to prior PD-1 inhibitor in the curative or metastatic setting.
•At least 18 years of age
•ECOG performance status ≤ 2
•Adequate bone marrow and organ function as defined below:
+9 more criteria

Exclusion Criteria

•Prior 5-FU given to treat RM-HNSCC.
•Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
•Currently receiving any other investigational agents.
•RM or incurable second primary SCC of cutaneous, nasopharynx, paranasal/nasal/sinus origin.
•DPYD deficiency (poor or intermediate metabolizer) as determined by next generation sequencing through blood or saliva (results of historical testing are accepted).
•Severe hepatic impairment (Child-Pugh C) or history of hepatitis B or C.
•Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-FU or other agents used in the study.
•Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of study registration.
•HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

May 31, 2026

Primary Completion Date

August 31, 2028

Completion Date

August 31, 2031

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Squamous Cell Carcinoma of Head and NeckMetastatic Squamous Cell CarcinomaRecurrent Squamous Cell Carcinoma of the Head and Neck

Interventions

5-Fluorouracil

DRUG

Contacts

Christine Auberle, MD

CONTACT

314-747-1459 auberlec@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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