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.
Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
Clinical T3-4a-stages
Any differentiation grade
Any histological subtype
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).
Parallel
Cisplatin
Drug10.5 mg/m2 body surface in 150ml saline
Doxorubicin
Drug2.1 mg/m2 body surface in 50ml saline
Peritoneal disease-free survival
Peritoneal disease-free survival (P-DFS) defined as no signs of peritoneal recurrence on (PET) CT and/or control laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy
Disease-free survival
Rate of disease-free survival (DFS) with at least 12 months of follow-up
Overall survival
Rate of overall survival with at least 12 months of follow-up
Length of stay
Length of stay (LOS) (Surgery = Day 0)
Postoperative toxicity
Rate of patients with 30 days postoperative toxicity (CTCAE)
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Odense University Hospital
Lead sponsor
Karolinska University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
