Clinical Research Directory

Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases

Colorectal cancer is the second leading cause of cancer death in France, with close to 50,000 new cases each year. About half of the patients develop liver, lung and/or peritoneal metastases during the course of the disease.Peritoneal involvement, which accounts for approximately 8,000 new cases per year, carries the poorest prognosis, notably because of its chemoresistance.For patients with resectable colorectal peritoneal metastases,recommended optimal management combines systemic chemotherapy with complete cytoreductive surgery(CRS)in an expert center.Hyperthermic IntraPeritoneal Chemotherapy(HIPEC)may be added to CRS to eradicate residual microscopic disease and potentially improve survival.Clinical evidence on HIPEC for colorectal peritoneal carcinomatosis is heterogeneous and dominated by a randomized trial reporting no survival benefit and increased morbidity, results attributed to the oxaliplatin-based HIPEC regimen used. A separate body of evidence suggests a benefit of mitomycin-C-based HIPEC, with manageable morbidity and preserved quality of life. National and international guidelines therefore allow mitomycin-C HIPEC, but the procedure remains controversial: according to French hospital discharge data, about half of the patients treated for colorectal peritoneal carcinomatosis receive CRS plus HIPEC and the other half CRS alone.HIPEC also raises funding and efficiency issues. No specific French diagnosis-related tariff (GHS)exists for CRS plus HIPEC, whereas the procedure is costly in terms of operating time,human and material resources, and is associated with prolonged hospital stays and complications. To date, no prospective comparative data on the efficiency of CRS plus HIPEC are available in France.ECO-CHIP is a national,multicenter, prospective, comparative,non-randomized, open, non-interventional study using a " here-elsewhere " design (French RIPH category 3). Each participating center follows its own routine practice: centers performing HIPEC treat included patients with CRS plus mitomycin-C HIPEC (innovative strategy), while centers not performing HIPEC treat included patients with CRS alone (reference strategy).No change in management, examination or procedure is imposed by the protocol.the only procedure added because of the research is the completion of self-administered questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29 and PERI-PROM) at inclusion and at months 1, 3, 6, 12, 18, 24 and 36 after cytoreductive surgery. The primary objective is to assess, from the French health care system perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System(SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity, postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life. Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival (expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone, hazard ratio 0.66) and quality-adjusted survival at an acceptable incremental cost per QALY gained. perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System (SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity,postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life. Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival(expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone,hazard ratio 0.66)and quality-adjusted survival at an acceptable incremental cost per QALY gained.A total of 398 patients 199per group are planned for inclusion in French digestive and surgical oncology departments over a 36-month enrolment period, each patient being followed for 36 months