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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Cancerologie de l'Ouest

About this trial

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 criteria

Qualifiers

ECOG performance status of 0 to 2;

Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);

PCI >15

Extended small bowell involvement

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Standard Medical Therapy
  • PIPAC

Treatment groups

114 Participants
are divided into 2 treatment groups