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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a procedure called PIPAC — a way of delivering chemotherapy directly into the abdominal cavity using a pressurized aerosol — can prevent stomach cancer from spreading to the lining of the belly (a complication called peritoneal carcinomatosis) in patients with locally advanced gastric cancer. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with stomach cancer that has grown into surrounding layers but has not spread to distant organs - Your cancer has been confirmed by tissue biopsy - A test (diagnostic laparoscopy) shows no cancer cells floating in your abdominal fluid - You have not had prior chemotherapy or radiation - You are physically well enough for surgery (good performance status) **You may NOT be eligible if...** - Your cancer has already spread to distant organs - You have already received chemotherapy or radiation - You have other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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