Study on the Effectiveness of PIPAC and Minimally Invasive Surgery in High-Risk Stomach Cancer Patients

Sponsor: Odense University Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06295094

Provider View

This clinical trial is testing whether a new method of delivering chemotherapy directly into the abdomen, called PIPAC, can improve survival rates for patients with high-risk stomach cancer when used alongside minimally invasive surgery.

Patient Parameters

Program Overview

The aim of this study is to find out if using a new chemotherapy method called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) right after a minimally invasive stomach surgery can help patients with high-risk stomach cancer live longer without the cancer returning. PIPAC is a technique where chemotherapy is sprayed directly into the abdomen, which may help target cancer cells more effectively than traditional methods. The study will compare this approach to the standard treatment to see if it offers better outcomes for patients.

Description

Stomach cancer, also known as gastric adenocarcinoma, is a common and serious type of cancer worldwide. While it is less common in Western countries, it remains prevalent in East Asia. The standard treatment for medically fit patients involves a type of surgery called D2 gastrectomy, which is often performed using minimally invasive techniques. Despite advances in treatment, many patients still experience cancer returning after surgery, leading to poor outcomes.

This study explores a new treatment approach that combines surgery with a special type of chemotherapy called PIPAC. PIPAC involves spraying chemotherapy directly into the abdomen, which may help reach cancer cells more effectively than traditional chemotherapy. This method has shown promise in treating other types of cancer, and researchers hope it can improve outcomes for stomach cancer patients as well.

The study will focus on patients with high-risk stomach cancer, particularly those with advanced stages of the disease. It will investigate whether PIPAC can reduce the risk of cancer spreading to the lining of the abdomen, a common and serious complication. Previous studies have shown that PIPAC can be safe and well-tolerated, and this trial aims to confirm its effectiveness in improving survival rates for these patients.

By participating in this trial, patients will receive the standard surgical treatment along with PIPAC, and their progress will be closely monitored to assess the impact on their cancer and overall health. The goal is to provide new insights into better treatment options for high-risk stomach cancer patients.

Eligibility Criteria

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.

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