Phase 2 Study Comparing Heated Versus Aerosolized Laparoscopic Chemotherapy Using Mitomycin C for Cancer Spread in the Abdomen

What this Trial Is About

Researchers are investigating treatment options for Peritoneal Carcinomatosis PC, a condition where cancer spreads inside the abdomen, causing pain and nutritional issues. The study compares two methods of delivering chemotherapy directly into the abdomen Heated Intra-Peritoneal Chemotherapy HIPEC and Pressurized Intraperitoneal Aerosol Chemotherapy PIPAC. Both methods use the chemotherapy drug mitomycin C but have not been directly compared for safety, tolerability, effectiveness, and overall value. Participants will be randomly assigned to receive either HIPEC or PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen for 90 minutes during surgery, repeated up to three times about six weeks apart. PIPAC delivers chemotherapy as a pressurized aerosol laparoscopically for 30 minutes, also repeated up to three times at similar intervals. Before treatment, diagnostic laparoscopies and biopsies will be performed to assess eligibility and collect tumor tissue for analysis. During the study, patients will undergo quality-of-life surveys at the start and after each chemotherapy treatment. Follow-up laparoscopies will check treatment effects and side effects. Although participants are followed for up to five years, no extra study visits are required after treatment. Researchers will monitor adverse events, surgical complications, treatment tolerability, and effectiveness over time to learn which method may offer better results for patients with PC.

Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)