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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: patrick.wagner@ahn.org
• Phone: 412-359-3731

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Next Generation Delivery System (NGDS) for SBRT in thorax and upper abdomen

  A study tests a new machine to deliver SBRT more quickly and comfortably for adults with thoracic or upper abdominal cancers.

  Recruiting at 2 sites Varian, a Siemens Healthineers Company · St Louis, Missouri and 1 other locations · NCT07824583

• FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum

  Aims to see if adding targeted radiotherapy and cadonilimab immunotherapy to standard second-line chemotherapy helps adults with colorectal cancer that’s spread only to the peritoneum.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07815834

• TLR9-based immunotherapy for peritoneal cancer with ascites

  This trial tests ACM-CpG injections into the abdomen to see if it’s safe and can help people with peritoneal metastases or malignant ascites from colorectal or appendiceal cancer.

  Recruiting Phase 1 Brown University · Providence, Rhode Island · NCT07658196

• Breath-hold technique to improve radiation accuracy for abdominal cancers

  This study tests whether using inhale and exhale breath holds during SBRT can better target abdominal tumors while protecting nearby organs.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07594691

• Repeated PIPAC plus standard platinum–taxane chemotherapy for advanced ovarian cancer with peritoneal spread

  This test sees if adding repeated cisplatin-based PIPAC to standard platinum–taxane chemotherapy helps women aged 18–75 with newly diagnosed FIGO IIIB–IIIC epithelial ovarian cancer and visible peritoneal carcinomatosis.

  Recruiting Phase 2 Moscow Regional Oncological Dispensary · Balashikha · NCT07514494

• Enhanced Recovery After Surgery for adults with peritoneal carcinomatosis undergoing cytoreductive surgery with or without HIPEC

  This project will try an Enhanced Recovery After Surgery (ERAS) program to see if it shortens hospital stays after cytoreductive surgery with or without HIPEC for adults with peritoneal carcinomatosis.

  Recruiting Fondazione del Piemonte per l'Oncologia · Candiolo, Turin and 1 other locations · NCT07493876

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.