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NOT YET RECRUITING
NCT06839092
PHASE3

Prophylactic PIPAC in Patients With High-risk Colorectal Cancer

Sponsor: Jeremy Meyer

View on ClinicalTrials.gov

Summary

In a multicentric randomized controlled trial, we will compare standard surgery (consisting in removal of the primary cancer) followed by 6 months of adjuvant chemotherapy associated with 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart), to standard surgery followed by 6 months of adjuvant systemic chemotherapy (routine treatment), in patients with colorectal cancer at high risk for metachronous peritoneal carcinomatosis (pT4 pN0-2 cM0 pMMR colorectal cancer of the colon, colorectal junction or high rectum and/or with positive cytology) in terms of 1-year and 3-year peritoneal metastasis-free survival (as measured by imaging and/or surgical exploration), 1-year and 3-year disease-free survival, as well as 1-year and 3-year overall survival. In terms of outcomes measurement, patients in both groups will benefit from diagnostic laparoscopy at 6 months from the index surgery, and standard surveillance consisting in clinical examination, CEA determination and thoraco-abdominal CT at 6, 12, 24, 36, 48 and 60 months after index surgery.

Official title: Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-01

Completion Date

2034-01

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

PROCEDURE

oxaliplatin-based PIPAC

Patients operated for pT4 pN0-2 cM0 pMMR colorectal cancer (of the colon, colorectal junction or high rectum) or patients operated for pT3-4 pN0-2 cM0 pMMR colorectal cancer with positive cytology or in patients with pT3-4 pN0-2 M1c pMMR colorectal cancer with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion, will undergo 6 months of adjuvant systemic chemotherapy associated with 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart). Each PIPAC session will include exploration laparoscopy (with PCI score), peritoneal lavage for cytology and biopsies of healthy peritoneum of the four quadrants + Douglas + omentum), and oxaliplatin-based PIPAC.

PROCEDURE

Control (Standard treatment)

Patients operated for pT4 pN0-2 cM0 pMMR colorectal cancer (of the colon, colorectal junction or high rectum) or patients operated for pT3-4 pN0-2 cM0 pMMR colorectal cancer with positive cytology or in patients with pT3-4 pN0-2 M1c pMMR colorectal cancer with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion, will undergo 6 months of adjuvant systemic chemotherapy, followed by exploration laparoscopy (including 300ml peritoneal lavage for cytology and seven punch peritoneal biopsies in the four quadrants of the abdomen, Douglas and omentum, as well as peritonectomy of 1 cm2) at 6 months after index surgery before entering a standard surveillance program.