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NOT YET RECRUITING
NCT06681038
PHASE2

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

Sponsor: Institut Cancerologie de l'Ouest

View on ClinicalTrials.gov

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

Official title: Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-02

Completion Date

2029-08

Last Updated

2024-11-08

Healthy Volunteers

No

Interventions

DRUG

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.

PROCEDURE

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.

Locations (15)

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

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, France

CHRU

Strasbourg, France

Centre Hospitalier TARBES

Tarbes, France

Institut de Cancérologie de Lorraine (ICL)

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France