Adjuvant Chemoimmunotherapy for Colorectal Cancer
- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil
and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole,
alfa interferon, or no treatment.
- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and
after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1
hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before
surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over
1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV
over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.
Allocation: Randomized, Primary Purpose: Treatment
Francesco Tonelli, MD
Universita Degli Studi di Florence - Policlinico di Careggi
United States: Federal Government