- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734691
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study (OPAC)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Marwan-Julien Sleiman
- Phone Number: 0041795533197
- Email: marwan.sleiman@hcuge.ch
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Arm
|
PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy
|
Experimental: Experimental Arm
|
PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 8 months
|
any clinical sign and/or morphological sign of peritoneal recurrence or death
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life C30
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPAC study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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