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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Patrick Wagner, MD, FACS
Study ID
NCT07282834
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Abdominal Cancer
  • Abdominal Cancer Patients
  • Peritoneal (Metastatic) Cancer
  • Peritoneal Carcinomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Heated intra-peritoneal chemotherapy — PROCEDURE
    Mitomyocin C 40 mg will be administered in divided doses (30mg at time zero and 10mg at 60 minutes) for a total of 90 minutes at 41-43 degrees Celsius. Laparoscopic HIPEC will then be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.
  • Aerosolized intra-peritoneal chemotherapy — PROCEDURE
    PIPAC will be performed with mitomycin C, 12.5mg/m2, delivered laparoscopically for 30 minutes at ambient temperature. Laparoscopic PIPAC or be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.

Study Details

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.

Key Dates

Start date
Jan 5, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2035
Completion
Nov 30, 2040

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy
    Laparoscopic intraperitoneal administration of mitomycin C chemotherapy through peritoneal catheters, heated intra-peritoneal chemotherapy (HIPEC) delivered during surgical procedures.
  • Active Comparator: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy
    Conventional administration of pressurized/aerosolized laparoscopic delivery of mitomycin C chemotherapy (PIPAC)

Primary Outcome Measure

Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events [ Time Frame: 150 days from Day #1 visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Allegheny Health Network West Penn HospitalPittsburghPennsylvania15224
Patrick Wagner, MD
[email protected]
412-359-3731
AHN Clinical Trial Contact Clinical Trial Contact
[email protected]
412-359-3731
Patrick Wagner, MD (PRINCIPAL_INVESTIGATOR)
Casey Allen, MD (SUB_INVESTIGATOR)
David Bartlett, MD (SUB_INVESTIGATOR)
Alexander Shannon, MD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
Allegheny Health Network West Penn Hospital· Pittsburgh, PA

Related Studies