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Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Sponsor: Jagiellonian University
Summary
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
Official title: A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2021-08-01
Completion Date
2026-12
Last Updated
2024-03-06
Healthy Volunteers
No
Conditions
Interventions
FLOT + HIPEC + Surgery
HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy
FLOT + Surgery
Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery
Locations (1)
Department of General, Oncological, Gastroenterological Surgery and Transplantology
Krakow, Lesser Poland Voivodship, Poland