A Phase 3 interventional study of oxaliplatin-based PIPAC and Control (Standard treatment) in Colorectal Cancer Control and Prevention, Colorectal Cancer and Colorectal Cancer Stage II, sponsored by Jeremy Meyer. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Jeremy Meyer · Phase 3, Interventional, and Prevention
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 160 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Jeremy Meyer is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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).
Procedure: oxaliplatin-based PIPAC
Standard surgery followed by 6 months of adjuvant systemic chemotherapy.
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 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.
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 (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.
Time frame: 1-year
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jeremy Meyer