Actively Recruiting
Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)
Led by Patrick Wagner, MD, FACS · Updated on 2026-02-27
200
Participants Needed
1
Research Sites
773 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females age 18 to 80 years.
- Biopsy-proven or clinically suspected peritoneal carcinomatosis.
- Received at least three months of standard systemic chemotherapy with persistent disease at randomization.
- Not a candidate for surgical cytoreduction at time of laparoscopy.
- Women of childbearing potential must have a negative pregnancy test and use contraception during the study.
- Ability to read, understand English, and consent for themselves.
You will not qualify if you...
- Eligible for definitive cytoreductive surgery at enrollment.
- Significant blood, liver, or kidney abnormalities as defined by specific laboratory values.
- Use of investigational drugs within 30 days before enrollment.
- Systemic therapy within 14 days before randomization.
- Allergy or contraindication to the chemotherapy used.
- Medical contraindication to laparoscopic or complex cytoreductive surgery.
- Pregnant or breastfeeding females.
- Likely non-compliance with study procedures as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Allegheny Health Network West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
P
Patrick Wagner, MD
CONTACT
A
AHN Clinical Trial Contact Clinical Trial Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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