Phase IV Study Comparing Surgery With or Without Mitomycin-C HIPEC in Treating Adults With Colon Cancer Peritoneal Metastases

What this Trial Is About

Researchers are evaluating whether adding Hyperthermic Intraperitoneal Chemotherapy HIPEC with Mitomycin C after complete surgical removal of peritoneal metastases in patients with colon cancer affects the chance of cancer returning in the abdomen. This phase IV clinical trial addresses uncertainties from prior research by focusing on the time patients remain free from peritoneal recurrence rather than overall survival. It excludes rectal cancers and patients with extensive peritoneal disease or incomplete surgery to better understand HIPECs role in this setting. Participants are randomly assigned to one of two groups one receiving complete cytoreductive surgery plus HIPEC with Mitomycin C delivered at 35 mgm2 in a heated peritoneal dialysis solution for 90 minutes with dose fractionation, and the other receiving surgery alone without HIPEC. The study corrects previous trial shortcomings by increasing HIPEC infusion time and limiting patient selection based on cancer spread and surgery completeness. During the trial, participants will be monitored for peritoneal recurrence over three years, with assessments including imaging and disease-free survival measures. Researchers will also track postoperative complications within 90 days after surgery and evaluate quality of life at multiple points before surgery, after chemotherapy, and at one and two years. The trial aims to provide detailed information on recurrence patterns, survival, and patient well-being over three years following treatment.

Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)