Brief 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

Conditions

• Peritoneal Metastases from Colorectal Cancer

Intervention / Treatment

• Drug: Standard Medical Therapy
• Procedure: PIPAC

Primary Outcome Measures

• 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.

Countries

France

Locations and Investigators

• Centre François Baclesse, Caen, France
  • Sharmini VARATHARAJAH, MD
  • Sharmini VARATHARAJAH, MD
• Centre Georges François Leclerc, Dijon, France
  • David ORRY, MD
  • David ORRY, MD
• CHU, Lille, France
  • Clarisse EVENO, MD
  • Clarisse EVENO, MD
• CHU Dupuytren, Limoges, France
  • Sylvaine DURAND, MD
  • Sylvaine DURAND, MD
• APHM La Timone, Marseille, France
  • Nicolas PIRRO, MD
  • Nicolas PIRRO, MD
• Institut de Cancérologie de Montpellier (ICM), Montpellier, France
  • Olivia SGABURA, MD
  • Olivia SGABURA, MD
• APHP Saint Louis, Paris, France
  • Diane GOERE, MD
  • Diane GOERE, MD
• APHP Hôpital Européen Georges Pompidou, Paris, France
  • Antoine MARIANI, MD
  • Antoine MARIANI, MD
• Hospices Civils de Lyon - Hôpital Lyon Sud, Pierre-Bénite, France
  • Vahan KEPENEKIAN, MD
  • Vahan KEPENEKIAN, MD
• Institut de Cancérologie de l'Ouest - Saint Herblain, Saint HERBLAIN, France
  • Frédéric DUMONT, MD
  • Frédéric DUMONT, MD
• Hôpital d'Instruction des Armées Bégin, Saint Mande, France
  • Anne-Cécile EZANNO, MD
  • Anne-Cécile EZANNO, MD
• CHRU, Strasbourg, France
  • Cécile BRIGAND, MD
  • Cécile BRIGAND, MD
• Centre Hospitalier TARBES, Tarbes, France
  • Amandine PINTO, Doctor
  • Amandine PINTO, MD
• Institut de Cancérologie de Lorraine (ICL), Vandoeuvre Les Nancy, France
  • Cécilia CERIBELLI, MD
  • Cécilia CERIBELLI, MD
• Gustave Roussy, Villejuif, France
  • Isabelle SOURROUILLE, MD
  • Isabelle SOURROUILLE, MD

Study Officials

• Frédéric DUMONT, MD (Principal Investigator) — Institut de Cancérologie de l'Ouest