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.
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.
Infraperitoneal rectal cancer (middle or low rectum).
Age <18 year old.
Age > 80 year old.
Hereditary colorectal cancer.
Parallel
oxaliplatin-based PIPAC
Procedure/SurgeryPatients 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.
Control (Standard treatment)
Procedure/SurgeryPatients 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.
1-year peritoneal metastasis-free survival,
The primary endpoint will be the 1-year peritoneal metastasis-free survival, defined as the absence of peritoneal carcinomatosis at 1 year after index surgery, as determined during surveillance. Peritoneal carcinomatosis can diagnosed by any existing modality (as part of a pragmatic approach), including imaging (practiced during surveillance and/or in emergency for ex. for bowel occlusion), surgical exploration (practiced during PIPAC sessions in the intervention group, but also at 6 months after index surgery in the control group, which decrease the risk potential detection bias) and/or pathology. Positive cytology during exploration laparoscopy performed during PIPAC session and/or in the control group will be considered as peritoneal metastasis and therefore as a positive primary outcome.
3-year peritoneal metastasis-free survival
Disease-free survival (DFS)
Overall survival (OS)
30-day incidence of complications
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Jeremy Meyer
Lead sponsor
University Hospital, Geneva
Sponsor institution
University Hospital, Geneva
Collaborator
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