Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum
OBJECTIVES: I. Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal
mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal
cancer originating from the colorectum.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center and mode of surgery. Patients are randomized to one of two treatment arms. Arm I:
Patients undergo complete resection of tumor on day 0. Patients then receive mitomycin
intraperitoneally (IP) over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5.
Patients then receive one of three systemic chemotherapy regimens for 6 months: Regimen I:
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on
days 1 and 2. Treatment repeats every 2 weeks. Regimen II: Patients receive fluorouracil IV
continuously for 7 weeks. Treatment repeats every 8 weeks. Regimen III: Leucovorin calcium
and fluorouracil are administered as per standard procedure. Arm II: Patients receive
treatment as in arm I but without early intraperitoneal chemotherapy. Patients are followed
every 3 months for 2 years.
PROJECTED ACCRUAL: At least 90 patients (45 per arm) will be accrued for this study.
Primary Purpose: Treatment
Dominique Elias, MD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government