Phase 2 Study Comparing Flat Dose Versus Weight-Based Dose of Heated Intraperitoneal Mitomycin C During Surgery for Advanced Gastrointestinal Cancer

What this Trial Is About

Researchers are evaluating two dosing methods of Mitomycin C delivered as heated intraperitoneal chemotherapy HIPEC during cytoreductive surgery CRS for patients with peritoneal carcinomatosis from advanced gastrointestinal cancers. This randomized phase 2 trial aims to compare flat dose versus weight-based dose Mitomycin C to determine if weight-based dosing achieves effective local drug concentrations with less systemic absorption and toxicity. The study focuses on patients with specific peritoneal malignancies who have limited treatment options and historically poor survival. Participants receive Mitomycin C during CRS with HIPEC, either as a flat dose 30 mg at minute 0 and 10 mg at minute 45 or a weight-based dose 9.5 mgm2 at minute 0 and 3 mgm2 at minute 45, totaling 12.5 mgm2. The chemotherapy is delivered directly to the peritoneal surfaces while heated to enhance drug penetration and effectiveness. The trial compares these two dosing strategies to assess differences in pharmacokinetics and systemic exposure. During the study, researchers will measure pharmacokinetic outcomes such as drug concentration over time, clearance, and half-life within approximately 20 hours post-treatment. Participants must be evaluated for eligibility, including performance status and organ function, and will be monitored for safety and treatment effects. The trial continues through surgery, chemotherapy delivery, and follow-up to better understand the optimal dosing approach for Mitomycin C in this setting.

Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC