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
Patrick Wagner, MD, FACS
200 participants
Jan 5, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Males or females age 18 to 80 years.
- Biopsy-proven or clinically suspected peritoneal carcinomatosis
- Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
- Not a candidate for surgical cytoreduction at the time of laparoscopy
- 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 the duration of the study.
- Must be able to read and understand English and consent for themselves
Exclusion Criteria9
- Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
- AST/SGOT > 2.5 times the upper limit of normal ALT/SGPT > 2.5 times the upper limit of normal Total bilirubin > 2.5 times the upper limit of normal Hemoglobin < 7 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 50,000/mm3
- Any investigational drug use within 30 days prior to enrollment.
- Systemic therapy within 14 days prior to randomization
- Allergy or medical contra-indication to chemotherapy utilized in this study
- Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
- Pregnant or lactating females.
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07282834