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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Intravenous 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.
In 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.
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
...and 5 more locations
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.
Time frame: From randomisation to 18 months after last patient randomisation
Overall survival (OS) between the two groups
Overall survival (OS) defined as the time between randomisation and death from any cause
Time frame: From randomisation to 18 months after last patient randomisation
EORTC QLQ-C30 questionnaire
Quality of life between the two groups evaluated by the score of EORTC QLQ-C30 questionnaire
Time frame: At enrollment, week 16 and week 32 after the start of treatment
EORTC QLQ-CR29 questionnaire
Quality of life between the two groups evaluated by the scores of EORTC QLQ-CR29 questionnaire
Time frame: At enrollment, week 16 and week 32 after the start of treatment
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.
Time frame: From randomisation to 18 months after last patient randomisation
Obstruction-free survival (OFS) between the two groups
Obstruction-free survival is defined as the time between the date of randomisation and the appearance of gastrointestinal obstruction requiring medication with high dose of corticosteroïd (\> 1mg/kg) or intervention as nasogastric decompression, intraluminal stenting, surgical bypass, or decompression stomy (gastrostomy or ileo/colostomy) or death.
Time frame: From randomisation to 18 months after last patient randomisation
Histological tumor response
Peritoneal regression grading score (PRGS) on biopsies performed at surgical exploration in both groups, and systematically during 1st and 2nd PIPAC procedure.
Time frame: At the end of the 12th course of treatment (week 24)
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