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NCT07419464 · ClinicalTrials.gov registry record · Phase 2
5-Fluorouracil Response and Optimization STudy (The FROST Trial)
A Phase 2 study, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT07419464 is a Phase 2 study that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 46 participants.
The verdict
NCT07419464, a Phase 2 study, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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.
Interventions
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2026-04-21 |
| Est. Completion | 2031-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07419464
The ClinicalTrials.gov registry entry for NCT07419464 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5-Fluorouracil is the first listed.
NCT07419464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07419464 about?
NCT07419464 is a clinical study titled "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...
What is the current status of trial NCT07419464?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2026-04-21. Estimated completion is 2031-07-31.
What interventions are being tested in trial NCT07419464?
The interventions under investigation include: 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT07419464?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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