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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00004931 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) and Oxaliplatin With 5-FU Plus LV for the Treatment of Patients With Stages II and III Carcinoma of the Colon |
| Enrollment: | 2492 |
| Study Start Date: | February 2000 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 6, 9, and 12 months; every 6 months for 4 years; and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,472 patients will be accrued for this study within 3 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 141 Study Locations| Study Chair: | J. Philip Kuebler, MD, PhD | Columbus Oncology Associates, Incorporated |
More Information
| Responsible Party: | Norman Wolmark, MD, NSABP Foundation, Inc. |
| ClinicalTrials.gov Identifier: | NCT00004931 History of Changes |
| Other Study ID Numbers: | NSABP C-07, CDR0000067615 |
| Study First Received: | March 7, 2000 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Federal Government |
|
stage II colon cancer stage III colon cancer |
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |