Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy to Prevent Colorectal Peritoneal Metastases (ProphyPIPAC)

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Peritoneal Metastases From Colorectal Cancer
Interventions
PROCEDURE

Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

"Laparoscopic exploration of the abdominal cavity with dissection of adhesions and biopsies of suspect findings (if needed).~PIPAC will be administered with oxaliplatin (92 mg/m2 body surface area in 150 ml dextrose solution) for 30 minutes under the following spraying conditions: cytostatic application at a rate of 30 ml/min, pressure of 1380 kilo-pascal over 30 minutes, and temperature of 22°C. One hour before the beginning of PIPAC, intravenous infusion of 5-fluorouracil (400 mg/m2) and folinic acid (20mg/m2) will be initiated. Standard protectionist procedures will be adopted to avoid contamination of operators and the environment with nebulized chemotherapy."

Trial Locations (1)

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

All Listed Sponsors
lead

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER