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NCT01011478 · ClinicalTrials.gov registry record · Phase 3
Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery
A Phase 3 study, sponsored by NSABP Foundation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT01011478: Clinical Trial Phase 3 study, sponsored by NSABP Foundation.
NCT01011478 is a Phase 3 study that was terminated before completion, run by NSABP Foundation. The registered enrollment target is 406 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01011478, a Phase 3 study, was terminated before completion, sponsored by NSABP Foundation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study Summary
RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether rosuvastatin is more effective than a placebo in treating colon cancer that was removed by surgery. PURPOSE: This randomized phase III trial is studying rosuvastatin to see how well it works compared with placebo in treating patients with stage I or stage II colon cancer that was removed by surgery.
Primary Outcome
Percentage of patients with occurrence of APMC+R event. APMC+R events include at least one adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence
Interventions
- OTHER placebo
- DRUG rosuvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
Why NCT01011478 stopped before completion
NCT01011478 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01011478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01011478 about?
NCT01011478 is a clinical study titled "Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery". RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether ...
What is the current status of trial NCT01011478?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2010-03. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01011478?
The interventions under investigation include: placebo (OTHER), rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT01011478?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01011478's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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