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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)

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ClinicalTrials.gov Identifier: NCT04734691
Recruitment Status : Not yet recruiting
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sleiman Marwan-Julien, University Hospital, Geneva

Study Description
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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


Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Procedure: PIPAC Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : November 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm Procedure: PIPAC
PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy
Active Comparator: Control Arm Procedure: PIPAC
PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 8 months ]
    any clinical sign and/or morphological sign of peritoneal recurrence or death


Secondary Outcome Measures :
  1. Quality of life C30 [ Time Frame: 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734691


Contacts
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Contact: Marwan-Julien Sleiman 0041795533197 marwan.sleiman@hcuge.ch

Sponsors and Collaborators
Sleiman Marwan-Julien
More Information
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Responsible Party: Sleiman Marwan-Julien, Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04734691    
Other Study ID Numbers: OPAC study
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases