Clinical trial NCT06839092: Prophylactic PIPAC in Patients with High-risk Colorectal Cancer
Official title: Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients with Colorectal Cancer: the PROPAC Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer Control and Prevention
Colorectal Cancer
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Keywords: Colorectal cancer
Peritoneal carcinomatosis
PIPAC
Pressurized intraperitoneal aerosol chemotherapy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2025-02-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 1-year peritoneal metastasis-free survival,
timeFrame: 1-year
Secondary outcomes:
measure: 3-year peritoneal metastasis-free survival
timeFrame: 3-year
measure: 3-year disease-free survival
timeFrame: 3-year
measure: 3-year overall survival
timeFrame: 3-year
Other outcomes:
Locations:
Study officials:
References: