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NCT00096278 · ClinicalTrials.gov registry record · Phase 3
Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 2,710
- Enrollment target
NCT00096278: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00096278 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 2,710 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (251% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096278, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,710 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer.
Primary Outcome
Where events are defined as recurrence, second primary cancer, or death from any cause
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- BIOLOGICAL Bevacizumab
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,710 participants |
| Start Date | 2004-09-15 |
| Est. Completion | 2012-12-31 |
| Phase | Phase 3 |
What the finished NCT00096278 record still lists
NCT00096278 is an interventional study that assigns participants to a tested intervention. Its 2,710 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (251% higher).
The record links to 0 conditions, and to 4 interventions - of which Fluorouracil is the first listed.
NCT00096278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00096278 about?
NCT00096278 is a clinical study titled "Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer". This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer. Drugs us...
What is the current status of trial NCT00096278?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,710 participants. The study started on 2004-09-15. Estimated completion is 2012-12-31.
What interventions are being tested in trial NCT00096278?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Bevacizumab (BIOLOGICAL), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT00096278?
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 NCT00096278's enrollment target sits among peer trials
2,710 83rd of 2000 higher than 1,918 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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