Heated versus aerosolized chemotherapy delivered into the abdomen for cancer that has spread to the peritoneum

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

This study will test whether heated (HIPEC) or aerosolized (PIPAC) mitomycin-based chemotherapy given into the abdomen works better and is safer for adults whose cancer has spread to the peritoneum.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT07282834 on ClinicalTrials.gov

What this trial studies

Up to 200 adults with peritoneal carcinomatosis who are not candidates for cytoreductive surgery will be randomized to receive three laparoscopic treatments of either heated intra‑peritoneal chemotherapy (HIPEC) or pressurized aerosol chemotherapy (PIPAC) approximately six weeks apart. Each procedure includes tissue biopsies for pathology and a small portion of tissue saved for laboratory research; mitomycin C is the chemotherapy used but is not being tested itself. Patients will undergo diagnostic laparoscopy before enrollment to confirm eligibility and again after treatment to evaluate response. The trial compares safety, tolerability, and effectiveness of the two delivery methods in a head‑to‑head randomized design over about 120–180 days of participation.

Who should consider this trial

Good fit: Adults aged 18–80 with biopsy-proven or clinically suspected peritoneal carcinomatosis who have had at least three months of prior systemic chemotherapy, are not candidates for cytoreductive surgery, and can consent in English are the intended participants.

Not a fit: Patients eligible for definitive cytoreductive surgery, those with major hematologic/hepatic/renal abnormalities, or those unable to undergo laparoscopic procedures are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the trial could identify the delivery method that offers better disease control, fewer side effects, or improved quality of life for patients with peritoneal spread of cancer.

How similar studies have performed: Both HIPEC and PIPAC have been used clinically and reported tumor responses or symptom benefit in prior series, but they have not been directly compared in a randomized trial of this size.

Eligibility criteria

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 the duration of the study.
6. Must be able to read and understand English and consent for themselves

Exclusion Criteria:

1. Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
2. 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
3. Any investigational drug use within 30 days prior to enrollment.
4. Systemic therapy within 14 days prior to randomization
5. Allergy or medical contra-indication to chemotherapy utilized in this study
6. Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
7. Pregnant or lactating females.
8. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Where this trial is running

Pittsburgh, Pennsylvania

• Allegheny Health Network West Penn Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Patrick Wagner, MD — Allegheny Health Network
• Study coordinator: Patrick Wagner, MD

Conditions: Peritoneal Cancer, Peritoneal Carcinomatosis, Abdominal Cancer, Abdominal Cancer Patients, intraperitoneal, peritoneal cavity, mitomycin-C, PIPAC