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NCT05780684 · ClinicalTrials.gov registry record · NA
Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer
A NA study of Colorectal Cancer and Esophagus Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05780684: Recruiting NA study of Colorectal Cancer and Esophagus Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
NCT05780684 is a NA study of Colorectal Cancer and Esophagus Cancer that is actively recruiting participants, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 36 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05780684, a NA study of Colorectal Cancer and Esophagus Cancer, is actively recruiting participants, sponsored by Dartmouth-Hitchcock Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.
Primary Outcome
The proportion of patients who receive dose-intensified infusional 5-FU (dosed at greater than or equal to 2,800 mg/m2) in Cycle 6 of the FOX regimen.
Conditions Studied
Interventions
- OTHER FOX dose-escalation algorithm
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT05780684 shows while recruiting
NCT05780684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which FOX dose-escalation algorithm is the first listed.
NCT05780684 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT05780684 about?
NCT05780684 is a clinical study titled "Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer". This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at...
What is the current status of trial NCT05780684?
This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2023-07-14. Estimated completion is 2026-12.
What conditions does trial NCT05780684 study?
This clinical trial studies the following conditions: Colorectal Cancer, Esophagus Cancer, Appendix Cancer, Small Bowel Cancer, Ampullary Cancer.
What interventions are being tested in trial NCT05780684?
The interventions under investigation include: FOX dose-escalation algorithm (OTHER).
Who is sponsoring clinical trial NCT05780684?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05780684 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05780684's enrollment target sits among peer trials
36 312th of 381 higher than 69 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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