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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPatrick Wagner, MD, FACS

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients who are eligible for definitive cytoreductive surgery at the time of enrollment

Any investigational drug use within 30 days prior to enrollment.

Systemic therapy within 14 days prior to randomization

Allergy or medical contra-indication to chemotherapy utilized in this study

Trial design

Treatments tested in this trial

  • Heated intra-peritoneal chemotherapy
  • Aerosolized intra-peritoneal chemotherapy

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Patrick Wagner, MD, FACS

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Sponsor institution