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
ECOG performance status of 0 to 2;
Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);
PCI >15
Extended small bowell involvement
Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;
Rectal cancer primary (tumor <15 cm from the anal verge);
Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
Complete or partial bowel obstruction unresponsive to medical treatment;
Institut Cancerologie de l'Ouest
Lead sponsor