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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: | 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.
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
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Institute of Huntsville | |
| Huntsville, Alabama, United States, 35801 | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91109-7013 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Comprehensive Cancer Centers of the Desert | |
| Palm Springs, California, United States, 92262 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| Kaiser Permanente-Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Saint Mary Medical Center - Long Beach | |
| Long Beach, California, United States, 90813-0887 | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| Sutter Health West Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Inc. | |
| Denver, Colorado, United States, 80209-5031 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-7106 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| George Washington University Medical Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Baptist Regional Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34239 | |
| MD Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Morton Plant Mease Health Care | |
| Clearwater, Florida, United States, 33756 | |
| Halifax Medical Center | |
| Daytona Beach, Florida, United States, 32114 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Medical College of Georgia Comprehensive Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| North Idaho Cancer Center | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Alexian Brothers Medical Center | |
| Elk Grove Village, Illinois, United States, 60007 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| Illinois Masonic Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| MBCCOP-Cook County Hospital | |
| Chicago, Illinois, United States, 60612 | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| West Suburban Hospital Medical Center | |
| Oak Park, Illinois, United States, 60302 | |
| United States, Indiana | |
| Cancer Treatment Centers of America at Goshen Health System | |
| Goshen, Indiana, United States, 46526 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Clarian Health Partners Inc. | |
| Indianapolis, Indiana, United States, 46206-1367 | |
| LaPorte Hospital | |
| LaPorte, Indiana, United States, 46350-0250 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Holden Comprehensive Cancer Center | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Kentucky | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| Lucille Parker Markey Cancer Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Norton Healthcare System | |
| Louisville, Kentucky, United States, 40202-5070 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Tulane University Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| National Naval Medical Center | |
| Bethesda, Maryland, United States, 20889-5000 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| Berkshire Medical Center | |
| Pittsfield, Massachusetts, United States, 01201 | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Michigan State University | |
| East Lansing, Michigan, United States, 48824 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Methodist Cancer Center - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Albany Regional Cancer Center | |
| Albany, New York, United States, 12208 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| Lincoln Medical and Mental Health Center | |
| Bronx, New York, United States, 10451 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Aultman Cancer Center | |
| Canton, Ohio, United States, 44710 | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45267-0502 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| Grant/Riverside Methodist Hospitals | |
| Columbus, Ohio, United States, 43214 | |
| Jewish Hospital of Cincinnati, Inc. | |
| Cincinnati, Ohio, United States, 45236 | |
| South Pointe Hospital - Cancer Care Center | |
| Warrensville Heights, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| St. Luke's Network - Bethlehem | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| York Hospital | |
| York, Pennsylvania, United States, 17315 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| Center for Oncology Research and Treatment, Medical City Hospital | |
| Dallas, Texas, United States, 75230 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Vermont | |
| Green Mountain Oncology Group | |
| Bennington, Vermont, United States, 05201 | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23507 | |
| Virginia Oncology Associates - Newport News | |
| Newport News, Virginia, United States, 23606 | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | |
| Roanoke, Virginia, United States, 24014 | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| United States, West Virginia | |
| Camcare Health | |
| Charleston, West Virginia, United States, 25304 | |
| Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26102 | |
| United States, Wisconsin | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| CCOP - Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Australia, New South Wales | |
| Australasian Gastro-Intestinal Trials Group | |
| Camperdown, New South Wales, Australia, 1450 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Canada, Quebec | |
| Jewish General Hospital - Montreal | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Royal Victoria Hospital - Montreal | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| St. Mary's Hospital Center | |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Puerto Rico | |
| MBCCOP - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Study Chair: | J. Philip Kuebler, MD, PhD | Columbus Oncology Associates, Incorporated |
More Information
| 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 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 |