Prophylactic PIPAC in Patients With High-risk Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oxaliplatin-based PIPAC, Control (Standard treatment).
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Control and Prevention, Colorectal Cancer, Colorectal Cancer Stage II, Colorectal Cancer Stage III. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial
Overview
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.
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 - 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 (i
Primary outcome measures
- 1-year peritoneal metastasis-free survival, [Time frame: 1-year]
Secondary outcome measures (5)
- 3-year peritoneal metastasis-free survival [Time frame: 3-year]
- Disease-free survival (DFS) [Time frame: 1-year, 3-years]
- Overall survival (OS) [Time frame: 1-year, 3-year]
- 30-day incidence of complications [Time frame: 30-day]
- EORTC QLQ-C30 score 29 [Time frame: 1 month, 2 months, 4 months, 6 months, 12 months, 24 months and 36 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06839092 · PROPAC