Comparing Heated and Aerosol-based Chemotherapy for Cancer Spread to the Abdominal Lining

Sponsor: Patrick Wagner, MD, FACS

Sponsor score: 0

ClinicalTrials ID:NCT07282834

Provider View

This study is exploring two different methods of delivering chemotherapy directly into the abdomen for patients with cancer that has spread to the abdominal lining. The goal is to find out which method is safer, more effective, and better tolerated.

Patient Parameters

Program Overview

This research is focused on improving treatment for Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen, causing pain and nutritional issues. There is no standard treatment, and doctors use various combinations of chemotherapy, surgery, and direct abdominal chemotherapy (IP chemotherapy). This study compares two IP chemotherapy methods: HIPEC, which uses heated chemotherapy during surgery, and PIPAC, which delivers chemotherapy as a pressurized aerosol during a minimally invasive procedure. The aim is to determine which method is safer, more effective, and better tolerated.

Description

The study involves using a chemotherapy drug called Mitomycin C, which is already approved for treating cancer. It works by stopping cancer cells from growing and spreading. Up to 200 patients will participate, and they will be randomly assigned to receive either HIPEC or PIPAC. Participants will be in the study for about 4 to 6 months.

Patients will undergo a standard diagnostic procedure to check if they are eligible for surgery to remove as much cancer as possible. Before starting treatment, small tissue samples will be taken for analysis. Patients will receive three rounds of chemotherapy, each about six weeks apart, during a minimally invasive procedure. Tissue samples will be collected during each treatment to study the effects on tumors.

After treatment, patients will have another procedure to assess the treatment's impact and check for side effects. Although patients will be followed for up to 5 years, no specific follow-up visits are required. Participants will also complete quality-of-life surveys to provide feedback on their health and daily activities.

Both HIPEC and PIPAC are standard treatments for PC, so there is no extra risk for participants. However, as with any treatment, there are potential risks like infection or injury to organs, but these are small and similar to what patients would face in regular care.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 80 years.
  • Diagnosed or suspected cancer spread to the abdominal lining.
  • Have received at least three months of standard chemotherapy, but the disease persists.
  • Not eligible for surgery to remove cancer at the time of the procedure.
  • Women of childbearing age must have a negative pregnancy test and use contraception during the study.
  • Must be able to read and understand English and consent to participate.

Exclusion Criteria

  • Eligible for surgery to remove cancer at the time of enrollment.
  • Significant blood, liver, or kidney issues as shown by specific lab tests.
  • Use of investigational drugs within 30 days before joining the study.
  • Received systemic therapy within 14 days before randomization.
  • Allergic or medically unable to receive the chemotherapy used in the study.
  • Unable to undergo minimally invasive or complex surgery.
  • Pregnant or breastfeeding women.
  • Individuals who may not follow study schedules or procedures.

Locations

FACILITYZIPCITYSTATE
Allegheny Health Network West Penn Hospital15224PittsburghPennsylvania

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