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The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.
Sponsor: Odense University Hospital
Summary
The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.
Official title: The Efficacy of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) Combined With CURativE Intent Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. A Multicentre, Randomised, Open-label Phase-II Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2024-09
Completion Date
2028-01
Last Updated
2024-03-06
Healthy Volunteers
No
Conditions
Interventions
Cisplatin
10.5 mg/m2 body surface in 150ml saline
Doxorubicin
2.1 mg/m2 body surface in 50ml saline
Locations (5)
City of Hope
Duarte, California, United States
Odense University Hospital
Odense C, Denmark
University Hospital Lille
Lille, France
Charité, University of Berlin
Berlin, Germany
Karolinska University Hospital
Stockholm, Sweden