Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Medical Therapy: 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.

PIPAC: 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.

Study summary

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

Eligibility

Primary outcome measure(s)

• Progression free survival (PFS) between the two groups — From randomisation to 18 months after last patient randomisation
  Progression free survival (PFS) is defined as the time (in months) from randomisation until the date of progression or death from any cause.

Trial sites (15)

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