S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00002593
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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 and giving drugs in different ways may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in different ways in treating patients with surgically removed stage II or stage III colon cancer at high risk of recurrence.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1135
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5-FU/Leucovorin/Levamisole leucovorin calcium levamisole hydrochloride: 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; leucovorin calcium: 20 mg/m\^2/day, IV, Days 1-5 of each cycle; 5-fluorouracil: 425 mg/m\^2/day, IV, Days 1-5 of each cycle; 5-FU/Leucovorin/Levamisole levamisole hydrochloride levamisole hydrochloride: 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; leucovorin calcium: 20 mg/m\^2/day, IV, Days 1-5 of each cycle; 5-fluorouracil: 425 mg/m\^2/day, IV, Days 1-5 of each cycle; Infusional 5-FU + Levamisole levamisole hydrochloride levamisole hydrochloride : 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; 5-fluorouracil: 250 mg/m\^2/day, continuous infusion, daily for 56 days x 3 cycles of 8 weeks. 5-FU/Leucovorin/Levamisole fluorouracil levamisole hydrochloride: 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; leucovorin calcium: 20 mg/m\^2/day, IV, Days 1-5 of each cycle; 5-fluorouracil: 425 mg/m\^2/day, IV, Days 1-5 of each cycle; Infusional 5-FU + Levamisole fluorouracil levamisole hydrochloride : 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; 5-fluorouracil: 250 mg/m\^2/day, continuous infusion, daily for 56 days x 3 cycles of 8 weeks.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Disease free survival Until progression
Related Research Topics
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Trial Locations
- Locations (60)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States