RecruitingPhase 2

Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)

United States200 participantsStarted 2026-01-05

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males or females age 18 to 80 years.
. Biopsy-proven or clinically suspected peritoneal carcinomatosis
. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
. Not a candidate for surgical cytoreduction at the time of laparoscopy
. 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.
. Must be able to read and understand English and consent for themselves

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events

Timeframe: 150 days from Day #1 visit

Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications

Timeframe: 150 days from Day #1 visit

Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events

Timeframe: 150 days from Day #1 visit

Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications

Timeframe: 150 days from Day #1 visit

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events

Timeframe: 150 days from Day #1 visit

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events

Timeframe: 150 days from Day #1 visit

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications

Timeframe: 150 days from Day #1 visit

Trial details

NCT IDNCT07282834

SponsorPatrick Wagner, MD, FACS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-12

Contact for this trial

Patrick Wagner, MD

412-359-3731 patrick.wagner@ahn.org

View on ClinicalTrials.gov More Peritoneal (Metastatic) Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males or females age 18 to 80 years.
. Biopsy-proven or clinically suspected peritoneal carcinomatosis
. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
. Not a candidate for surgical cytoreduction at the time of laparoscopy
. 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.
. Must be able to read and understand English and consent for themselves

Exclusion criteria

What they're measuring

Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events

Timeframe: 150 days from Day #1 visit

Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications

Timeframe: 150 days from Day #1 visit

Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events

Timeframe: 150 days from Day #1 visit

Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications

Timeframe: 150 days from Day #1 visit

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events

Timeframe: 150 days from Day #1 visit

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events

Timeframe: 150 days from Day #1 visit

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications

Timeframe: 150 days from Day #1 visit