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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
Sleiman Marwan-Julien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Carcinomatosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 27, 2021
    Last Updated
    January 27, 2021
    Sponsor
    Sleiman Marwan-Julien
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    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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