Patrick Wagner, MD, FACS
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.
Mitomycin C is the chemotherapy that is being administered but it is not being evaluated in the study. Mitomycin C is an FDA-approved antineoplastic antibiotic, meaning it's a type of chemotherapy drug used to treat cancer. It works by interfering with DNA synthesis, which is essential for cell growth and division. By disrupting DNA, mitomycin C can prevent cancer cells from multiplying and spreading. The study will enroll up to 200 patients who will be randomly assigned (like the flip of a coin) to receive either HIPEC or PIPAC. Participants will be active on the study for 120-180 days. Dur…
Inclusion Criteria: 1. Males or females age 18 to 80 years. 2. Biopsy-proven or clinically suspected peritoneal carcinomatosis 3. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization 4. Not a candidate for surgical cytoreduction at the time of laparoscopy 5. Women at least 18 years of age of childbearing potential must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for…
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.
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.
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