RecruitingPhase 2NCT07282834

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

Randomized Phase II Trial of Heated Vs. Pressurized/Aerosolized Chemotherapy (HIPEC vs. PIPAC) for Peritoneal Carcinomatosis

Sponsor

Patrick Wagner, MD, FACS

Enrollment

200 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Peritoneal Carcinomatosis Abdominal Cancer Peritoneal (Metastatic) Cancer Abdominal Cancer Patients

Summary

This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or "IP" chemotherapy). The study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Aerosolized intra-peritoneal chemotherapy and a procedure called Heated intra-peritoneal chemotherapy for people with abdominal cancer, abdominal cancer patients, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHeated intra-peritoneal chemotherapy

Mitomyocin C 40 mg will be administered in divided doses (30mg at time zero and 10mg at 60 minutes) for a total of 90 minutes at 41-43 degrees Celsius. Laparoscopic HIPEC will then be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.

PROCEDUREAerosolized intra-peritoneal chemotherapy

PIPAC will be performed with mitomycin C, 12.5mg/m2, delivered laparoscopically for 30 minutes at ambient temperature. Laparoscopic PIPAC or be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.