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The FROST Trial: 5-Fluorouracil for Head and Neck Cancer

This study, called The FROST Trial, is looking at two different ways to give the chemotherapy drug 5-Fluorouracil (5-FU) to people with head and neck squamous cell carcinoma that has come back or spread (recurrent or metastatic). You might be able to join if you have this type of cancer and have already received platinum and PD-1 inhibitor treatments. The study will compare giving 5-FU for two days every two weeks versus four days every three weeks. We want to see how well each treatment shrinks the cancer (overall response rate) and what side effects occur. The study aims to enroll 46 participants, but its current status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to one of two 5-FU treatment groups. It is a Phase II trial, designed to evaluate the effectiveness and safety of the treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, overall response rate, will be measured from the start of treatment through its completion, estimated to be up to 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07419464

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~46 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:5-Fluorouracil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Start of treatment through completion of treatment (estimated time up to 4 months)

Conditions

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

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Christine Auberle, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Christine Auberle, MD
[email protected]
314-747-1459
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 100 K/cumm
Hemoglobin ≥ 8.0 g/dL
Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3 x IULN)
AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase (ALP) ≤ 3.0 x IULN. For subjects with documented bone metastasis, ALP ≤ 5.0 x IULN.
Serum creatinine \<3 mg/dL or creatinine clearance \> 30 mL/min by Cockcroft- Gault.
The effects of 5-FU on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after last dose of 5-FU
Recovery to baseline or ≤ grade 1 from AEs due to prior therapy, unless AEs are clinically nonsignificant and/or stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, or ≤ grade 2 neuropathy are permitted.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion

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.

What this trial measures

  • Overall response rate (ORR)Start of treatment through completion of treatment (estimated time up to 4 months)

    * ORR, defined as CR and PR per RECIST v1.1. * Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.