Prophylactic PIPAC in Patients With High-risk Colorectal Cancer

NCT ID: NCT06839092

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2034-01-31

Brief 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.

Conditions

Colorectal Cancer Control and Prevention; Colorectal Cancer; Colorectal Cancer Stage II; Colorectal Cancer Stage III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prophylactic PIPAC

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).

Group Type: EXPERIMENTAL

oxaliplatin-based PIPAC

Intervention Type: PROCEDURE

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.

No prophylactic PIPAC

Standard surgery followed by 6 months of adjuvant systemic chemotherapy.

Group Type: ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients operated (in emergency or elective settings) for colorectal cancer (of the colon, colorectal junction or high rectum).
• Definitive pathological stage pT4 pN0-2 cM0 pMMR and/or pT3-4 pN0-2 cM0 pMMR with positive cytology and/or pT3-4 pN0-2 M1c pMMR with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion (small indeterminate pulmonary nodules to be followed are accepted)
• Performance status 0-1.
• Age > 18 years.
• Written informed consent.

Exclusion Criteria

• Infraperitoneal rectal cancer (middle or low rectum).
• Age <18 year old.
• Age > 80 year old.
• Hereditary colorectal cancer.
• dMMR/MSI colorectal cancer.
• Inflammatory bowel disease.
• Distant metastasis (outside limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion; small indeterminate pulmonary nodules to be followed are accepted)
• Neo-adjuvant treatment.
• Pregnancy or lactation.
• Immunosuppression.
• Unable to provide informed consent.
• Previous cytoreductive surgery (CRS) (outside limited resection of peritoneal carcinomatosis during index surgery).
• Contraindication to laparoscopy (e.g. severe adhesions, peritonitis).
• Contraindication to and/or no adjuvant chemotherapy.
• History of allergic reaction to oxaliplatin or other platinum-containing compounds.
• Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault equation).
• Myocardial insufficiency, defined as NYHA class > 2.
• Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
• Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Jeremy Meyer

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Meyer

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Jeremy Meyer, MD, PhD

Role: CONTACT

jeremy.meyer@hug.ch

+41795533248

Other Identifiers

PROPAC

Identifier Type: -

Identifier Source: org_study_id