About this trial

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.

Eligibility criteria

Qualifiers

Gastric or Gastroesophageal junction Siewert type III adenocarcinomas

Clinical T3-4a-stages

Any differentiation grade

Any histological subtype

Disqualifiers

Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds.

Renal impairment, defined as glomerular filtration rate (GFR) < 40 ml/min (Cockcroft-Gault Equation).

Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4.

An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL).

Trial design

Treatments tested in this trial

  • Cisplatin
  • Doxorubicin

Treatment groups

264 Participants
are divided into 2 treatment groups

Locations

5
Denmark
Odense University Hospital5000, Odense C Denmark
France
University Hospital Lille Lille France
Germany
Charité, University of Berlin Berlin Germany
Sweden
Karolinska University Hospital Stockholm Sweden

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Karolinska University Hospital

Collaborator