Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.

PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Calcium; Calcium, Dietary; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal cancer

• Peritoneal carcinoma extension ≤ 25 (Sugarbaker Index) (determined intraoperatively)

• Planning to receive standard systemic chemotherapy

• Chemotherapy for metastatic cancer should be initiated 3 months after surgery

• No extraperitoneal metastases, including liver and lung metastasis

• No carcinomatosis of other origin besides colorectal, in particular appendical carcinomatosis

• Macroscopically complete resection (R1) or surgical reduction of tumor to a residual thickness ≤ 1 mm (R2) is possible

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Life expectancy > 12 weeks

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 3 times ULN

• Alkaline phosphatase ≤ 3 times ULN

• Creatinine ≤ 1.25 times ULN

• Eligible for surgery

• No peripheral neuropathy > grade 3

• Not pregnant or nursing

• No other cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

• No inability to submit to follow-up medical testing for geographical, social, or psychological reasons

• Affiliated with a social security program

• Not deprived of liberty or under supervision

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemohyperthermia

• No concurrent participation in another study of first-line therapy for this cancer