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Starting soon Phase 2

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

NCT06295094 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 2
Started
2024-09
Last updated
2024-03-06

Condition(s) studied

Gastric CancerChemotherapy, AdjuvantPeritoneal MetastasesMinimally Invasive Surgical Procedures

Investigational drug(s) / intervention(s)

Cisplatin →Doxorubicin →

Cisplatin: 10.5 mg/m2 body surface in 150ml saline

Doxorubicin: 2.1 mg/m2 body surface in 50ml saline

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion criteria * Gastric or Gastroesophageal junction Siewert type III adenocarcinomas * Clinical T3-4a-stages 1. Any differentiation grade 2. 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. Exclusion criteria * 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.

Primary outcome measure(s)

  • Peritoneal disease-free survival — 12 months
    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

Trial sites (5)

FacilityCityRegionStatus
City of Hope Duarte California
Odense University Hospital Odense C Denmark
University Hospital Lille Lille France
Charité, University of Berlin Berlin Germany
Karolinska University Hospital Stockholm Sweden

More Odense University Hospital trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06295094 on ClinicalTrials.gov ↗ ← All trials in Sweden