Colorectal Cancer Control and PreventionPhase 3PROPACNCT06839092
Prophylactic PIPAC in Patients With High-risk Colorectal Cancer
A Phase 3 study testing oxaliplatin-based PIPAC in people with Colorectal Cancer Control and Prevention and Colorectal Cancer, run by Jeremy Meyer.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Control and Prevention, Colorectal Cancer, Colorectal Cancer Stage II
- What is being tested?
- oxaliplatin-based PIPAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial
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.
- Conditions
- Colorectal Cancer Control and Prevention, Colorectal Cancer, Colorectal Cancer Stage II, Colorectal Cancer Stage III
- Being tested
- oxaliplatin-based PIPAC, Control (Standard treatment)
- Keywords
- Colorectal cancer, Peritoneal carcinomatosis, PIPAC, Pressurized intraperitoneal aerosol chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin-based PIPACProcedure or surgery
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.
Control (Standard treatment)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic PIPAC | Experimental | 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). Receives: Procedure: oxaliplatin-based PIPAC |
| No prophylactic PIPAC | Active comparator | Standard surgery followed by 6 months of adjuvant systemic chemotherapy. Receives: Procedure: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-year
Secondary outcomes (5)
3-year peritoneal metastasis-free survival
Measured: 3-year
Disease-free survival (DFS)
Measured: 1-year, 3-years
Overall survival (OS)
Measured: 1-year, 3-year
30-day incidence of complications
Measured: 30-day
EORTC QLQ-C30 score 29
Measured: 1 month, 2 months, 4 months, 6 months, 12 months, 24 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2032 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeremy Meyer
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Jeremy Meyer, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839092
- Sponsor's protocol ID
- PROPAC
- Acronym
- PROPAC
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06839092
- Acronym / sponsor ID
- PROPAC / PROPAC
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Jeremy MeyerUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic PIPAC | Experimental | Procedure: oxaliplatin-based PIPACStandard 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). |
| No prophylactic PIPAC | Active comparator | Procedure: Control (Standard treatment)Standard surgery followed by 6 months of adjuvant systemic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- Infraperitoneal rectal cancer (middle or low rectum).
- Age <18 year old.
- Age > 80 year old.
- Hereditary colorectal cancer.
- dMMR/MSI colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatin-based PIPACPatients 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. | Procedure or surgery | Prophylactic PIPAC |
| 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 (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. | Procedure or surgery | No prophylactic PIPAC |
Primary outcome
1-year peritoneal metastasis-free survival,
Time frame: 1-year
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Cancer Control and Prevention
Active, not recruitingPhase 3
S0820, Adenoma and Second Primary Prevention Trial
Colorectal Neoplasms
Not yet recruiting
Life Expectancy-informed Colorectal Cancer Screening
Colorectal Cancer Control and Prevention
Not yet recruiting
Optical Diagnosis of Neoplasia Using Artificial Intelligence
Polyps Colorectal, Colonoscopy
Recruiting
Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
Cascade Testing, Lynch Syndrome
RecruitingObservational study
Prediction Model of Colorectal Adenoma Recurrence-Carcinogenesis Risk With TCM-WM Multimodal Feature Fusion
Colorectal Cancer Control and Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxaliplatin-based PIPAC in people with Colorectal Cancer Control and Prevention and Colorectal Cancer, run by Jeremy Meyer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Meyer, MD, PhD (+41795533248, jeremy.meyer@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year peritoneal metastasis-free survival, (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.