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NOT YET RECRUITING
NCT06295094
PHASE2

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Cisplatin

10.5 mg/m2 body surface in 150ml saline

DRUG

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