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Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)
The goal of this clinical trial is to learn if Pressurized intraperitoneal aerosol chemotherapy (PIPAC) significantly improve the progression-free survival (PFS) in patients with advanced peritoneal metastasis from colorectal cancer. Researchers will compare 2 strategies, systemic treatments (chemotherapy + targeted therapy) corresponding to standard treatment with or without intraperitoneal oxaliplatin (PIPAC) to see if PIPAC improve the progression-free survival. Participants will: * receive a standard treatment every 2 weeks for 12 cycles of intravenous FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF) in the both arms. * receive up to a maximum of 4 PIPAC every 6 weeks with pressurized aerosol containing oxaliplatin in experimental arm. * receive a maintenance treatment until progression or until the onset of severe toxicity after 12 cycles. * be asked to perform a CT scan and carcinoembryonic antigen (CEA) assay every 8 weeks until progression
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre François Baclesse
Caen, France
Centre Georges François Leclerc
Dijon, France
CHU
Lille, France
CHU Dupuytren
Limoges, France
APHM La Timone
Marseille, France
Institut de Cancérologie de Montpellier (ICM)
Montpellier, France
APHP Saint Louis
Paris, France
APHP Hôpital Européen Georges Pompidou
Paris, France
Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite, France
Institut de Cancérologie de l'Ouest - Saint Herblain
Saint-Herblain, France
Start Date
February 1, 2025
Primary Completion Date
August 1, 2029
Completion Date
August 1, 2029
Last Updated
November 8, 2024
114
ESTIMATED participants
Standard Medical Therapy
DRUG
PIPAC
PROCEDURE
Lead Sponsor
Institut Cancerologie de l'Ouest
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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