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RECRUITING
NCT07282834
PHASE2

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

Sponsor: Patrick Wagner, MD, FACS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01-05

Completion Date

2040-11

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

PROCEDURE

Heated 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.

PROCEDURE

Aerosolized 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.

Locations (1)

Allegheny Health Network West Penn Hospital

Pittsburgh, Pennsylvania, United States