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.
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
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
Parallel
Heated intra-peritoneal chemotherapy
Procedure/SurgeryMitomyocin 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/SurgeryPIPAC 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.
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events
Frequency of drug-related adverse events following HIPEC as assessed by CTCAE v5
Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications
Frequency of surgical complications following HIPEC
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events
Severity of drug-related adverse events following HIPEC as assessed by CTCAE v5
Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications
Severity of surgical complications following HIPEC as assessed by using Clavien-Dindo scale
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Serological indicators of tumor response following HIPEC using serum levels of CEA, CA19-9 or CA-125 as applicable in individual patients
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Serological indicators of tumor response following PIPAC using serum levels of CEA, CA19-9 or CA-125 as applicable in individual patients
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Radiographic indicators of tumor response following HIPECusing RECIST criteria, when available.
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Radiographic indicators of tumor response following PIPAC using RECIST criteria, when available
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Patrick Wagner, MD, FACS
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor institution
