Peritoneal CarcinomatosisPhase 2OPACNCT04734691
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
A Phase 2 study testing PIPAC in people with Peritoneal Carcinomatosis, run by Sleiman Marwan-Julien.
Trial summary
Colorectal cancer is the third most common cancer in men and second in women. It represent 345'346 new cases per year in Europe and 134'349 in the United States of America. The peritoneal cavity is the second most frequent site, after liver, for colorectal cancer relapse.Peritoneal carcinomatosis (PC) is found in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- PIPAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 < age ≤ 75 years old with Performance status (WHO) ≤ 2 Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI ≥ 15 (No complete resectable PC) Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI < 15 + liver or pulmonary unresectable metastases PCI < 15 but with progression at the restaging after the first line of chemotherapy Unresectable peritoneal relapse secondary to cytoreduction surgery
Who cannot join
- Patients with clinically significant ascites (> 3000 cc)
- Pleural effusion requiring evacuation for respiratory failure
- Small bowel occlusion with no possible food intake
- Presence of comorbidities, notably serious chronic diseases or organ failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study : OPAC Study
Colorectal cancer is the third most common cancer in men and second in women. It represent 345'346 new cases per year in Europe and 134'349 in the United States of America. The peritoneal cavity is the second most frequent site, after liver, for colorectal cancer relapse.Peritoneal carcinomatosis (PC) is found in approximately 5 % of patients diagnosed with colorectal cancer and 24% of patients with synchronous metastasis at the time of diagnosis. Eight percent of colorectal cancer patient will develop PC during the course of their disease .
Currently systemic chemotherapy is the standard of care for the treatment of unresectable peritoneal carcinomatosis from colorectal cancer with a median survival rate of 16.3 months Peritoneal carcinomatosis has a poor response to systemic chemotherapy due to a weak penetration of agents into the peritoneum.
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A new approach of intraperitoneal carcinomatosis is now developed: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is used to deliver intraperitoneal chemotherapy. It enhances the effect of chemotherapy because of the physical properties of aerosol and pressure.
PIPAC is a safe with a 23% morbidity and tolerated technic that is now well described.
We want to conduct a study to prove or infirm the superiority of PIPAC associated with systemic chemotherapy compare to systemic chemotherapy alone in peritoneal carcinomatosis from colorectal cancer
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- PIPAC
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACProcedure or surgery
PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Procedure: PIPAC |
| Control Arm | Active comparator | Not described Receives: Procedure: PIPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
any clinical sign and/or morphological sign of peritoneal recurrence or death
Measured: 8 months
Secondary outcomes (1)
Quality of life C30
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sleiman Marwan-Julien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sleiman Marwan-Julien, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734691
- Sponsor's protocol ID
- OPAC study
- Acronym
- OPAC
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study : OPAC Study
- ClinicalTrials.gov ID
- NCT04734691
- Acronym / sponsor ID
- OPAC / OPAC study
- Conditions
- Peritoneal Carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sleiman Marwan-JulienUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Feb 2021 (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.
Colorectal cancer is the third most common cancer in men and second in women. It represent 345'346 new cases per year in Europe and 134'349 in the United States of America. The peritoneal cavity is the second most frequent site, after liver, for colorectal cancer relapse.Peritoneal carcinomatosis (PC) is found in approximately 5 % of patients diagnosed with colorectal cancer and 24% of patients with synchronous metastasis at the time of diagnosis. Eight percent of colorectal cancer patient will develop PC during the course of their disease .
Currently systemic chemotherapy is the standard of care for the treatment of unresectable peritoneal carcinomatosis from colorectal cancer with a median survival rate of 16.3 months Peritoneal carcinomatosis has a poor response to systemic chemotherapy due to a weak penetration of agents into the peritoneum.
A new approach of intraperitoneal carcinomatosis is now developed: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is used to deliver intraperitoneal chemotherapy. It enhances the effect of chemotherapy because of the physical properties of aerosol and pressure.
PIPAC is a safe with a 23% morbidity and tolerated technic that is now well described.
We want to conduct a study to prove or infirm the superiority of PIPAC associated with systemic chemotherapy compare to systemic chemotherapy alone in peritoneal carcinomatosis from colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Procedure: PIPAC |
| Control Arm | Active comparator | Procedure: PIPAC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 < age ≤ 75 years old with Performance status (WHO) ≤ 2 Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI ≥ 15 (No complete resectable PC) Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI < 15 + liver or pulmonary unresectable metastases PCI < 15 but with progression at the restaging after the first line of chemotherapy Unresectable peritoneal relapse secondary to cytoreduction surgery
Key exclusion criteria (4 listed)
- Patients with clinically significant ascites (> 3000 cc)
- Pleural effusion requiring evacuation for respiratory failure
- Small bowel occlusion with no possible food intake
- Presence of comorbidities, notably serious chronic diseases or organ failure
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 |
|---|---|---|
| PIPACPIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy | Procedure or surgery | Control Arm, Experimental Arm |
Primary outcome
Progression free survival
Time frame: 8 months
any clinical sign and/or morphological sign of peritoneal recurrence or death
1 secondary outcome
Quality of life C30
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PIPAC in people with Peritoneal Carcinomatosis, run by Sleiman Marwan-Julien.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwan-Julien Sleiman (0041795533197, marwan.sleiman@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 8 months). 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 2 Feb 2021.