Actively Recruiting
Randomized Phase II Trial of Heated Versus Pressurized/Aerosolized Chemotherapy (HIPEC vs. PIPAC) for Peritoneal Carcinomatosis
Led by Patrick Wagner, MD, FACS · Updated on 2026-02-27
200
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for Peritoneal Carcinomatosis (PC), a condition where cancer spreads inside the abdomen, causing pain and nutritional issues. The study compares two methods of delivering chemotherapy directly into the abdomen: Heated Intra-Peritoneal Chemotherapy (HIPEC) and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). Both methods use the chemotherapy drug mitomycin C but have not been directly compared for safety, tolerability, effectiveness, and overall value. Participants will be randomly assigned to receive either HIPEC or PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen for 90 minutes during surgery, repeated up to three times about six weeks apart. PIPAC delivers chemotherapy as a pressurized aerosol laparoscopically for 30 minutes, also repeated up to three times at similar intervals. Before treatment, diagnostic laparoscopies and biopsies will be performed to assess eligibility and collect tumor tissue for analysis. During the study, patients will undergo quality-of-life surveys at the start and after each chemotherapy treatment. Follow-up laparoscopies will check treatment effects and side effects. Although participants are followed for up to five years, no extra study visits are required after treatment. Researchers will monitor adverse events, surgical complications, treatment tolerability, and effectiveness over time to learn which method may offer better results for patients with PC.
CONDITIONS
Brief 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...
- Male or female aged 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
- Able to read, understand English, and provide informed consent
You will not qualify if you...
- Eligible for definitive cytoreductive surgery at enrollment
- Significant blood, liver, or kidney problems as shown by specific lab test limits
- Use of any investigational drug within 30 days before enrollment
- Systemic therapy within 14 days before randomization
- Allergy or contraindication to chemotherapy used in this study
- Medical contraindication to laparoscopic or complex cytoreductive surgery
- Pregnant or breastfeeding females
- Expected non-compliance with study schedule or procedures as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 12 to 18 weeks
Participants receive three rounds of chemotherapy administered laparoscopically using either heated intra-peritoneal chemotherapy (HIPEC) or pressurized/aerosolized intra-peritoneal chemotherapy (PIPAC), each about six weeks apart. Biopsies of tumor tissue will be collected at each treatment for analysis.
3 laparoscopic treatment visits
Duration - Within a few weeks after the last treatment
Participants undergo a final laparoscopy to assess the effects of treatment and check for side effects.
1 follow-up laparoscopy visit
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
A
AHN Clinical Trial Contact Clinical Trial 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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