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
Sponsors and collaborators
Odense University Hospital
Lead sponsor
Karolinska University Hospital
Collaborator