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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
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Information provided by: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
ClinicalTrials.gov Identifier: | NCT00004931 |
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: | Treatment, Randomized, Active Control |
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 2011 |
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.
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.
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:
Study Chair: | J. Philip Kuebler, MD, PhD | Columbus Oncology Associates, Incorporated |
Responsible Party: | NSABP Foundation, Inc. ( Norman Wolmark, MD ) |
Study ID Numbers: | NSABP C-07, CDR0000067615 |
Study First Received: | March 7, 2000 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00004931 History of Changes |
Health Authority: | United States: Federal Government |
stage II colon cancer stage III colon cancer |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Leucovorin Trace Elements Folinic Acid Intestinal Diseases Immunosuppressive Agents Rectal Diseases |
Intestinal Neoplasms Carcinoma Calcium, Dietary Oxaliplatin Digestive System Diseases Vitamins Fluorouracil Gastrointestinal Neoplasms Micronutrients Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |