Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study (OPAC)
Primary Purpose
Peritoneal Carcinomatosis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PIPAC
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Carcinomatosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm
Control Arm
Arm Description
Outcomes
Primary Outcome Measures
Progression free survival
any clinical sign and/or morphological sign of peritoneal recurrence or death
Secondary Outcome Measures
Quality of life C30
Full Information
NCT ID
NCT04734691
First Posted
January 27, 2021
Last Updated
January 27, 2021
Sponsor
Sleiman Marwan-Julien
1. Study Identification
Unique Protocol Identification Number
NCT04734691
Brief Title
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
Acronym
OPAC
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sleiman Marwan-Julien
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Title
Control Arm
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PIPAC
Intervention Description
PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy
Primary Outcome Measure Information:
Title
Progression free survival
Description
any clinical sign and/or morphological sign of peritoneal recurrence or death
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Quality of life C30
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwan-Julien Sleiman
Phone
0041795533197
Email
marwan.sleiman@hcuge.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
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