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RECRUITING
NCT04597294
PHASE3

Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

Sponsor: Jagiellonian University

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

FLOT + HIPEC + Surgery

HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy

COMBINATION_PRODUCT

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