Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer
- Compare the progression-free survival of elderly patients with unresectable metastatic
colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising
fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.
- Compare the tumor response rate and overall survival of patients treated with these
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter, prospective study. Patients are stratified
according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%),
associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80
years), alkaline phosphatase level (≤ 2 times normal vs > 2 times normal), and prior
adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV
continuously over 22 hours on days 1 and 2.
- Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV
continuously over 46 hours on days 1 and 2.
- Arm III: Patients receive leucovorin calcium and fluorouracil as in arm I and
irinotecan hydrochloride IV over 90 minutes on day 1.
- Arm IV: Patients receive leucovorin calcium and fluorouracil as in arm II and
irinotecan hydrochloride as in arm III.
In all arms, treatment repeats every 14 days in the absence of disease progression or
Patients undergo surgery within 3-10 weeks after completing chemotherapy.
Quality of life is assessed at baseline and then every 2 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Emmanuel Mitry, MD, PhD
Hopital Ambroise Pare