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)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Scroll for more (50 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States