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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: Recruiting Phase 2 study, sponsored by Washington University School of Medicine.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* 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.
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 |
What NCT07419464 shows while recruiting
NCT07419464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Fluorouracil is the first listed.
NCT07419464 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07419464's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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