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NCT06839092 | NOT YET RECRUITING | Colorectal Cancer Control and Prevention

Prophylactic PIPAC in Patients with High-risk Colorectal Cancer
Sponsor:

Jeremy Meyer

Information provided by (Responsible Party):

Jeremy Meyer

Brief Summary:

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), we will compare standard surgery (consisting in removal of the primary cancer) followed by 3 months of adjuvant chemotherapy + 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart), to standard surgery followed by 3 months of adjuvant systemic chemotherapy, in terms of 1-year peritoneal metastasis-free survival, 3-year.

Condition or disease

Colorectal Cancer Control and Prevention

Colorectal Cancer

Colorectal Cancer Stage II

Colorectal Cancer Stage III

Intervention/treatment

oxaliplatin-based PIPAC

Control (Standard treatment)

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients with Colorectal Cancer: the PROPAC Randomized Clinical Trial
Actual Study Start Date : 2026-01
Estimated Primary Completion Date : 2032-01
Estimated Study Completion Date : 2034-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients operated (in emergency or elective surgery) for colorectal cancer (of the colon, colorectal junction or high rectum).
  • * Definitive pathological stage pT4 pN0-2 cM0 pMMR and/or pT4 pN0-2 cM0 pMMR with positive cytology and/or pT4 pN0-2 M1c pMMR with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and not other distant lesion
  • * Performance status 0-1.
  • * Age \> 18 years.
  • * Written informed consent.
Exclusion Criteria
  • * Age \<18 year old.
  • * Hereditary 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 not other distant lesion.
  • * Neo-adjuvant treatment.
  • * Pregnancy or lactation.
  • * Immunosuppression.
  • * Unable to provide informed consent.
  • * Previous cytoreductive surgery (CRS).
  • * 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 haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
  • * dMMR/MSI colorectal cancer.
Prophylactic PIPAC in Patients with High-risk Colorectal Cancer

Location Details

NCT06839092

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