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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00215956
The ClinicalTrials.gov registry entry for NCT00215956 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which topotecan is the first listed.
NCT00215956 reports 0 study locations.
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.
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