RecruitingNot ApplicableNCT06784765

Preventive Use of PIPAC in Locally Advanced Gastric Cancer.

Preventive Use of Pressurized Intraperitoneal Aerosol Chemotherapy in Locally Advanced Gastric Cancer: A Non-Randomized Controlled Study


Sponsor

National Research Oncology and Transplantology Center, Kazakhstan

Enrollment

160 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related mortality. In patients with locally advanced gastric cancer, multimodal treatment strategies, including perioperative chemotherapy, have significantly improved survival rates. Despite these advances, peritoneal carcinomatosis (PC) remains a serious problem, occurring in 60% of cases after radical surgery. PC is associated with poor prognosis and limited treatment options. Intra-abdominal chemotherapy, particularly hyperthermic intraperitoneal chemoperfusion (HIPEC), has demonstrated advantages in the treatment of PC. However, a new technique, pressurized intraperitoneal aerosolized chemotherapy (PIPAC), is emerging as a promising alternative. PIPAC delivers chemotherapeutic agents directly to the peritoneal surface as an aerosol, allowing deeper penetration of drugs into tumor implants while minimizing toxicity and invasiveness. This study hypothesizes that the addition of PIPAC as a preoperative treatment for patients with locally advanced gastric cancer may reduce the incidence of peritoneal carcinomatosis compared to standard therapy. The primary objective of this study is to determine whether preoperative PIPAC reduces the incidence of peritoneal carcinomatosis in these patients.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Adults aged 18-70 years with histologically confirmed locally advanced gastric adenocarcinoma (T3-4N0-3M0), ECOG performance status 0-2, and negative peritoneal cytology.
  • Signed informed consent
  • Aged 18-70 years
  • ECOG performance status 0-2
  • Histologically confirmed adenocarcinoma of the stomach (T3-4N0-3M0)
  • Negative peritoneal cytology from diagnostic laparoscopy
  • No prior chemotherapy or radiotherapy

Exclusion Criteria6

  • Presence of distant metastases
  • Positive peritoneal cytology
  • Previous cancer treatment (chemotherapy, radiotherapy, or surgery)
  • Severe comorbid conditions contraindicating surgery or chemotherapy
  • Pregnancy or lactation
  • Known hypersensitivity to study drugs

Interventions

PROCEDUREIntervention Group

Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) +gastrectomy with D2 lymphadenectomy

PROCEDUREControl Group

Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy


Locations(1)

National Research Oncology Centre

Astana, Kazakhstan

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NCT06784765


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