NCT06839092Not yet recruitingPhase 3
Prophylactic PIPAC in Patients With High-risk Colorectal Cancer
Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 30 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 16 Feb 2025
- Start date
- Jan 2026
- Primary completion date
- Jan 2032
- Lead sponsor
- Jeremy Meyer
- Diseases
- Colorectal cancer
- NCT number
- NCT06839092
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 160
- From Jan 2026 to the primary completion date, Jan 2032
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Previous cytoreductive surgery (CRS) (outside limited resection of peritoneal carcinomatosis during index surgery).
- Contraindication to and/or no adjuvant chemotherapy.
Other illness
- Infraperitoneal rectal cancer (middle or low rectum).
- Hereditary colorectal cancer.
- dMMR/MSI colorectal cancer.
- Inflammatory bowel disease.
- History of allergic reaction to oxaliplatin or other platinum-containing compounds.
- Myocardial insufficiency, defined as NYHA class \> 2.
Lab values
- Renal impairment, defined as GFR \< 50 ml/min, (Cockcroft-Gault equation).
- 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.
Age
- Age \<18 year old.
- Age \> 80 year old.
Other
- Neo-adjuvant treatment.
- Pregnancy or lactation.
- Immunosuppression.
- Unable to provide informed consent.
- Contraindication to laparoscopy (e.g. severe adhesions, peritonitis).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.