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COMPLETED Phase 2

5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer

NCT00308516 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 66 participants
Start Date 2006-03
Est. Completion 2012-02
Phase Phase 2

Sponsor

SCRI Development Innovations

63 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00308516

The ClinicalTrials.gov registry entry for NCT00308516 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00308516 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Florida, Georgia, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00308516?

This trial is sponsored by SCRI Development Innovations, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial