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NCT00303628 · ClinicalTrials.gov registry record · Phase 3
Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer
A Phase 3 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Terminated
- Registry status
- Phase 3
- Development phase
- 355
- Enrollment target
NCT00303628: Clinical Trial Phase 3 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT00303628 is a Phase 3 study that was terminated before completion, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 355 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00303628, a Phase 3 study, was terminated before completion, sponsored by ECOG-ACRIN Cancer Research Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 355 participants
- Enrollment target
Study Summary
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.
Primary Outcome
Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate.
Interventions
- DRUG bevacizumab
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2006-05-11 |
| Est. Completion | 2019-02-11 |
| Phase | Phase 3 |
Why NCT00303628 stopped before completion
NCT00303628 is an interventional study that assigns participants to a tested intervention. The registered 355 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 (54% lower).
The record links to 0 conditions, and to 4 interventions - of which bevacizumab is the first listed.
NCT00303628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00303628 about?
NCT00303628 is a clinical study titled "Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer". Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the...
What is the current status of trial NCT00303628?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 355 participants. The study started on 2006-05-11. Estimated completion is 2019-02-11.
What interventions are being tested in trial NCT00303628?
The interventions under investigation include: bevacizumab (DRUG), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG).
Who is sponsoring clinical trial NCT00303628?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00303628's enrollment target sits among peer trials
355 1025th of 2000 higher than 975 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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