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;
Parallel
Standard Medical Therapy
DrugIntravenous doublet chemotherapy FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF). Administered every 2 weeks for 12 cycles. Dosage and administration at recommended doses.
PIPAC
Procedure/SurgeryIn addition to standard systemic treatment, patients receive also four PIPAC procedures with pressurized aerosol containing oxaliplatin. The PIPAC procedure is repeated up to a maximum of 4 times every 6 weeks.
Progression free survival (PFS) between the two groups
Progression free survival (PFS) is defined as the time (in months) from randomisation until the date of progression or death from any cause.
Overall survival (OS) between the two groups
Overall survival (OS) defined as the time between randomisation and death from any cause
EORTC QLQ-C30 questionnaire
Quality of life between the two groups evaluated by the score of EORTC QLQ-C30 questionnaire
EORTC QLQ-CR29 questionnaire
Quality of life between the two groups evaluated by the scores of EORTC QLQ-CR29 questionnaire
Peritoneal progression free survival (PPFS) between the two groups
Peritoneal progression free survival defined as the time between the date of randomisation and the date of peritoneal progression or death from any cause.
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This trial is not recruiting at the moment. You can still explore other options:
