Study of Standard versus Intensified Hyperthermic Intraperitoneal Chemotherapy with 5-Fluorouracil for Colorectal Cancer with Peritoneal Metastases

What this Trial Is About

Researchers are evaluating treatments for patients with colorectal cancer who have peritoneal metastases, with or without limited liver metastases. This study combines a dose titration phase and an open-label randomized control trial using registry-based follow-up to compare the effectiveness of two types of hyperthermic intraperitoneal chemotherapy HIPEC. The study aims to understand if adding irinotecan and 5-fluorouracil 5-FU to the standard oxaliplatin HIPEC improves outcomes. Follow-up will assess recurrence, survival, complications, and quality of life up to five years. Participants will undergo cytoreductive surgery CRS followed by either the standard HIPEC with oxaliplatin and intravenous 5-fluorouracil during surgery, or an intensified HIPEC combining oxaliplatin, irinotecan, and a 24-hour postoperative infusion of 5-FU through abdominal drains. The 5-FU dose will be given in two equal injections through drains clamped for 16 hours. The dose escalation part monitors small groups of patients for 30 days before adjusting doses, while the randomized phase assigns patients intraoperatively to either treatment. The long-term follow-up uses registry data to track outcomes without extra study visits. During the study, patients will be monitored for recurrence-free survival at 24 months, overall survival and recurrence at 5 years, postoperative complications within 30 days, and quality of life over 3 years. Specific evaluations, adverse event reporting, and eligibility data are collected within the HIPEC registry. The trial includes standard laboratory tests and clinical assessments to ensure safety and treatment tolerability. Participants will be followed through routine care and registry records for up to five years after treatment.

Efficacy of Hyperthermic Intraperitoneal Chemotherapy