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NCT00308516 · ClinicalTrials.gov registry record · Phase 2
5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer
A Phase 2 study of Colorectal Cancer and Rectal Cancer, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 14
- Study locations
NCT00308516: Completed Phase 2 study of Colorectal Cancer and Rectal Cancer, sponsored by SCRI Development Innovations.
NCT00308516 is a Phase 2 study of Colorectal Cancer and Rectal Cancer that has completed, run by SCRI Development Innovations. The registered enrollment target is 66 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00308516, a Phase 2 study of Colorectal Cancer and Rectal Cancer, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation, and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the treatment of stage II and III rectal cancer. Recent evidence has proven fluorouracil/leucovorin (FL) in combination with bevacizumab is superior to FL alone and when combined with irinotecan is superior to (irinotecan plus fluorouracil/leucovorin (IFL) alone. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy, radiation, and chemotherapy in the adjuvant treatment of a common solid tumor.
Primary Outcome
The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
- PROCEDURE Radiation Therapy
Study Locations (14)
Florida
- Florida Cancer Specialists - Fort Myers
- Integrated Community Oncology Network - Jacksonville
- Watson Clinic Center for Cancer Care and Research - Lakeland
Georgia
- Northeast Georgia Medical Center - Gainesville
- Wellstar Cancer Research - Marietta
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Tennessee Oncology - Nashville
Alabama
- Northeast Alabama Regional Medical Center - Anniston
Arkansas
- Northeast Arkansas Clinic - Jonesboro
Kentucky
- Consultants in Blood Disorders and Cancer - Louisville
Pennsylvania
- Consultants in Medical Oncology and Hematology - Drexel Hill
South Carolina
- Spartanburg Regional Medical Center - Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00308516 record still lists
NCT00308516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT00308516 lists 14 locations in 10 states (Florida, Georgia, Tennessee).
Frequently Asked Questions
What is clinical trial NCT00308516 about?
NCT00308516 is a clinical study titled "5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer". This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation, and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the treatment of stage II and III rect...
What is the current status of trial NCT00308516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2006-03. Estimated completion is 2012-02.
What conditions does trial NCT00308516 study?
This clinical trial studies the following conditions: Colorectal Cancer, Rectal Cancer, Cancer of the Rectum.
What interventions are being tested in trial NCT00308516?
The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG), Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00308516?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00308516 being conducted?
This trial has 14 study locations across Alabama, Arkansas, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00308516's enrollment target sits among peer trials
66 251st of 381 higher than 130 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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