Clinical Research Directory
Browse clinical research sites, groups, and studies.
Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)
Sponsor: Institut Cancerologie de l'Ouest
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
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.
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