Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer
OBJECTIVES: I. Compare overall and disease free survival in patients with completely
resected stage II or III colon cancer randomized to adjuvant chemotherapy with bolus
fluorouracil and leucovorin calcium with levamisole vs continuous infusion fluorouracil with
levamisole.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, T stage (T1 vs T2 vs T3 vs T4a), N stage (N0 vs N1 vs N2-3), and time from surgery
until registration (21-28 vs 29-35 days). Patients are randomized to one of two treatment
arms. Arm I: Patients receive leucovorin calcium IV immediately followed by fluorouracil IV
on days 1 through 5 of weeks 1, 5, 9, 14, 19, and 24, and oral levamisole 3 times a day for
3 days on days 1-3. Courses repeat every 2 weeks for 6 months. Arm II: Patients receive
levamisole as in arm I plus fluorouracil by continuous IV infusion for 8 weeks. Treatment
with fluorouracil repeats every 10 weeks for 3 courses. Treatment continues in the absence
of disease progression or unacceptable toxicity. Patients are followed at 9 months and 12
months, then every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the study over
approximately 5.5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare effectiveness of bolus 5-FU, leucovorin, levamisole vs continuous infusion 5-FU, levamisole as adjuvant therapy for patients with colon cancer, measured in overall survival
At death
No
Elizabeth A. Poplin, MD
Study Chair
Cancer Institute of New Jersey
United States: Federal Government
CDR0000063773
NCT00002593
December 1994
March 2005
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |