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

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.

Eligibility

Inclusion Criteria:

1. Males or females age 18 to 80 years.
2. Biopsy-proven or clinically suspected peritoneal carcinomatosis
3. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
4. Not a candidate for surgical cytoreduction at the time of laparoscopy
5. 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.
6. Must be able to read and understand English and consent for themselves

Exclusion Criteria:

1. Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
2. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:

   AST/SGOT \> 2.5 times the upper limit of normal ALT/SGPT \> 2.5 times the upper limit of normal Total bilirubin \> 2.5 times the upper limit of normal Hemoglobin \< 7 gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 50,000/mm3
3. Any investigational drug use within 30 days prior to enrollment.
4. Systemic therapy within 14 days prior to randomization
5. Allergy or medical contra-indication to chemotherapy utilized in this study
6. Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
7. Pregnant or lactating females.
8. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Conditions5

Locations1 site

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