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

Starting soon · Phase 2

Conditions studied: Gastric Cancer, Chemotherapy, Adjuvant, Peritoneal Metastases, Minimally Invasive Surgical Procedures

In brief

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.

Key facts

Study ID

NCT06295094

Run by

Odense University Hospital

People needed

264

Starts

2024-09-01

Expected to finish

2028-01-01

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
• Clinical T3-4a-stages
• Any differentiation grade
• Any histological subtype
• Clinical T2-stage
• a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
• Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy.
• Any clinical nodal-stage
• clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted)
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
• Age 18 - 80 years
• Undergoing robotic or laparoscopic D2 gastrectomy
• Able and willing to provide written informed consent and to comply with the clinical study protocol
• Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception.

You may not qualify if…

• 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).
• An inadequate haematological function, defined as absolute neutrophil count (ANC) <1.5 x 109/l and platelets <100 x 109/l.
• Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives.

Where it is running

• 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

Full record on ClinicalTrials.gov

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