Actively Recruiting
Study on Surgery and Heated Chemotherapy HIPEC for Advanced Gastric Cancer with Limited Spread
Led by Ukrainian Society of Clinical Oncology · Updated on 2026-01-13
200
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the outcomes of combining hyperthermic intraperitoneal chemoperfusion HIPEC with curative-intent gastrectomy in patients who have resectable locally-advanced and limited-metastatic gastric cancer with a low peritoneal cancer index. This study addresses the challenge that surgery combined with systemic chemotherapy or immunotherapy may not always remove microscopic cancer deposits or prevent peritoneal spread, especially in T4 tumors or those with positive peritoneal washings. The goal is to reduce the risk of peritoneal progression by adding HIPEC after surgery. Participants will undergo curative-intent gastrectomy followed immediately by a single dose of HIPEC during the same operation. The HIPEC procedure uses mitomycin C and cisplatin administered according to a standardized protocol. The study groups include patients with T4a or T4b tumors or positive peritoneal cytology, and those with low peritoneal cancer index less than 7 who receive cytoreduction of visible peritoneal nodules before HIPEC. During the study, participants will be monitored for up to five years to assess the rate of peritoneal recurrence as the primary outcome. Secondary outcomes include distant recurrence rates, complications related to intraperitoneal chemotherapy and surgery within 30 days, overall survival, relapse-free survival over five years, and treatment-related quality of life measured six months after treatment. The study involves follow-up assessments and questionnaires to evaluate these outcomes comprehensively.
CONDITIONS
Brief Title
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Research Team
O
Oleksiy Dobrzhanskyi, MD
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