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NCT00215956 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Carcinoma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00215956: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00215956 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00215956, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is an open-label, single center, phase I study designed to determine the MTD or oral topotecan as a radiosensitizing agent in the treatment of rectal cancer patients. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45GY) over five weeks.
Primary Outcome
Dose escalation to determine MTD that can be given with radiation.
Interventions
- DRUG topotecan
- PROCEDURE surgery
- PROCEDURE radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2001-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 1 |
What the finished NCT00215956 record still lists
NCT00215956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which topotecan is the first listed.
NCT00215956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00215956 about?
NCT00215956 is a clinical study titled "A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Carcinoma". This is an open-label, single center, phase I study designed to determine the MTD or oral topotecan as a radiosensitizing agent in the treatment of rectal cancer patients. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (4...
What is the current status of trial NCT00215956?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2001-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00215956?
The interventions under investigation include: topotecan (DRUG), surgery (PROCEDURE), radiation (PROCEDURE).
Who is sponsoring clinical trial NCT00215956?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00215956's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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