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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Kazakhstan
National Research Oncology Centre
RECRUITING
Astana
Contact Information
Primary
Altay Kerimkulov, MD
altay.kerimkulov@gmail.com
+77014382825
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 160
Treatments
Experimental: PIPAC+FLOT
◦ Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.
Active_comparator: FLOT
Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Science and Higher Education of the Republic of Kazakhstan
Leads: National Research Oncology and Transplantology Center, Kazakhstan

This content was sourced from clinicaltrials.gov

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