Comparing Heated vs. Aerosol Chemotherapy for Abdominal Cancer Spread
This study is for people with peritoneal carcinomatosis (cancer that has spread to the lining of the abdomen). It compares two ways to deliver chemotherapy directly into the abdomen: Heated Intra-Peritoneal Chemotherapy (HIPEC) and Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC). Both methods use the chemotherapy drug mitomycin C. HIPEC involves circulating heated mitomycin C during surgery, while PIPAC delivers it as a spray during a laparoscopic procedure. The study aims to see which method causes fewer side effects and surgical complications. You may be eligible if you are between 18 and 80 years old, have biopsy-proven or suspected peritoneal carcinomatosis, and have received at least three months of standard chemotherapy.
- Study design
- This interventional study plans to enroll up to 200 participants who will be randomly assigned to receive either HIPEC or PIPAC. The phase of the study is not specified.
- What's involved
- You would undergo diagnostic laparoscopies, tissue biopsies, and receive three rounds of either HIPEC or PIPAC chemotherapy, each about six weeks apart. You would be active in the study for 120-180 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Adverse events and surgical complications will be measured up to 150 days from your first visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Patrick Wagner, MD · PRINCIPAL_INVESTIGATOR · Allegheny Health Network
Who to contact
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What this trial measures
- Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events150 days from Day #1 visit
Frequency of drug-related adverse events following HIPEC as assessed by CTCAE v5
- Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications150 days from Day #1 visit
Frequency of surgical complications following HIPEC
- Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events150 days from Day #1 visit
Severity of drug-related adverse events following HIPEC as assessed by CTCAE v5
- Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications150 days from Day #1 visit
Severity of surgical complications following HIPEC as assessed by using Clavien-Dindo scale
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events150 days from Day #1 visit
Frequency of drug-related adverse events following PIPAC as assessed by CTCAE v5
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events150 days from Day #1 visit
Severity of drug-related adverse events following PIPAC as assessed by CTCAE v5
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications150 days from Day #1 visit
Frequency of surgical complications following PIPAC
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications150 days from Day #1 visit
Severity of surgical complications as assessed following PIPAC by using Clavien-Dindo scale
- Heated intra-peritoneal chemotherapy (HIPEC) Tolerability150 days from Day #1 visit
The relative tolerability of HIPEC as determined by length of hospital stay
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability150 days from Day #1 visit
The relative tolerability of PIPAC as determined by length of hospital stay
- Heated intra-peritoneal chemotherapy (HIPEC) Tolerability150 days from Day #1 visit
The relative tolerability of HIPEC as determined by usage of pain medication in opioid equivalents prior to discharge
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability150 days from Day #1 visit
The relative tolerability of PIPAC as determined by usage of pain medication in opioid equivalents prior to discharge
- Heated intra-peritoneal chemotherapy (HIPEC) Tolerability150 days from Day #1 visit
The relative tolerability of HIPEC as determined by patient-reported outcomes using the Short Form-20 instrument
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability150 days from Day #1 visit
The relative tolerability of PIPAC as determined by patient-reported outcomes using the Short Form-20 instrument