Trial Information

Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence

OBJECTIVES: I. Compare the effect of second look surgery with or without intraperitoneal
mitomycin and fluorouracil on the 3 year survival rate of patients with colorectal cancer
who are at high risk for peritoneal cavity cancer. II. Compare the quality of life of
patients treated with these regimens. III. Compare the toxicity of these regimens in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, risk group, presence of symptoms (yes vs no), and isolated disease (yes vs no).
After primary surgery, all patients receive 6 months of chemotherapy consisting of
leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks.
Patients then undergo second look surgery or laparoscopy at 8-12 months. Second look surgery
or laparoscopy may be performed earlier if markers increase progressively for unknown
reasons or symptoms of peritoneal cancer occur. Patients with recurrent disease that can be
resected are randomized to one of two treatment arms. Patients with no residual disease or
with unresectable disease are followed for survival. Arm I: Patients undergo complete
resection of all detectable lesions followed immediately by intraperitoneal (IP) mitomycin
on day 0 and fluorouracil IP on days 1-4. Patients also receive systemic chemotherapy
consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus, followed by
fluorouracil IV over 22 hours on days 1 and 2. Systemic chemotherapy repeats every 2 weeks
for 6 months. Arm II: Patients undergo complete or partial resection and then receive
systemic chemotherapy as in arm I. Quality of life is assessed at baseline and then every 4
months for 3 years. All patients (including nonrandomized patients) are followed every 4
months for 3 years.

PROJECTED ACCRUAL: A total of 152 patients (76 randomized) will be accrued for this study.