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NCT04406857 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04406857: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04406857 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04406857, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of ropidoxuridine and how well it works when added to the usual chemotherapy treatment (capecitabine) during radiation therapy for the treatment of patients with stage II-III rectal cancer. Ropidoxuridine may help radiation therapy work better by making cancer cells more sensitive to the radiation therapy. Chemotherapy drugs, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out whether ropidoxuridine in addition to capecitabine and radiation therapy works better in treating patients with rectal cancer.
Primary Outcome
The maximum-tolerated dose is defined as the dose below which 2 or more of 6 patients experience dose-limiting toxicities attributable to ropidoxuridine.
Interventions
- DRUG Capecitabine
- RADIATION Radiation Therapy
- DRUG Ropidoxuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 1 |
Why NCT04406857 stopped before completion
NCT04406857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT04406857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04406857 about?
NCT04406857 is a clinical study titled "Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer". This phase I trial studies the side effects and best dose of ropidoxuridine and how well it works when added to the usual chemotherapy treatment (capecitabine) during radiation therapy for the treatment of patients with stage II-III rectal cancer. Ropidoxuridine may help radiation therapy work bette...
What is the current status of trial NCT04406857?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-03-17. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT04406857?
The interventions under investigation include: Capecitabine (DRUG), Radiation Therapy (RADIATION), Ropidoxuridine (DRUG).
Who is sponsoring clinical trial NCT04406857?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04406857's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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