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
Who is this study for? Patients with Gastric Cancer
What treatments are being studied? FLOT4+Surgery
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Gastric cancer confirmed histopathologically in tumor specimens.
• Age 18-75 years.
• Advanced gastric cancer cT3 / cT4a / N0-3b.
• No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
• Written consent to participate in the study.
Locations
Other Locations
Poland
Department of General, Oncological, Gastroenterological Surgery and Transplantology
RECRUITING
Krakow
Contact Information
Primary
Piotr Richter, Professor
piotr.richter@uj.edu.pl
+48124002400
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 600
Treatments
Experimental: Perioperative FLOT + prophylactic HIPEC + surgery
After 4 doses of preoperative FLOT chemotherapy diagnostic laparoscopy will be performed - patients without distant metastases will be randomised, in those randomised to experimental arm HIPEC with irinotecan will be performed (a dose of 300 mg/m2 body surface area will be administered over 45 minutes at a temperature of 42 degrees Celsius)
Active_comparator: Perioperative FLOT + surgery
Standard treatment regimen for advanced gastric cancer
Related Therapeutic Areas
Sponsors
Leads: Jagiellonian University