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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOdense University Hospital

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

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Karolinska University Hospital

Collaborator