NCT00002593

S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed

Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,135 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil	Given IV as described in Arm Description
DRUG	leucovorin calcium	Given IV as described in Arm description.
DRUG	levamisole hydrochloride	Given as described in arm description

Timeline

• Start date: 1994-12-01
• Primary completion: 1999-12-01
• Completion: 2005-03-01
• First posted: 2004-08-31
• Last updated: 2013-01-03

Locations

60 sites across 4 countries: United States, Canada, Puerto Rico, South Africa