drugset / Trial / NCT04597294

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

NCT04597294 ↗

Phase 3 Recruiting 600 enrolled Jagiellonian University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2021-08-01
Primary completion
2026-01
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 300 mg/m2 Other
Background Docetaxel Small molecule 50 mg/m2 —
Background Leucovorin Small molecule 200 mg/m2 —
Background Oxaliplatin Small molecule 85 mg/m2 —
Background fluorouracil Small molecule 2600 mg/m2 —

Indications