Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
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- STATUS
- Recruiting
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- End date
- Dec 3, 2026
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- participants needed
- 600
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- sponsor
- Jagiellonian University
Summary
The study was designed to evaluate the efficacy of perioperative FLOT4 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.
Description
This is a randomized, multicenter, clinical trial in which 598 patients with advanced gastric cancer at high risk of peritoneal metastases are randomly allocated to receive either preoperative hyperthermic intraperitoneal chemotherapy (HIPEC) plus gastrectomy (experimental group) or gastrectomy alone (control group). All patients, regardless of allocation, will additionally receive 4 cycles of FLOT4 chemotherapy (docetaxel 60 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 and 5-fluorouracil 2600 mg/m2) before surgery HIPEC and 4 cycles of FLOT4 chemotherapy after gastrectomy. The main outcome is frequency of peritoneal recurrence by 6-months post-operative. Patients will be followed for 5 years and undergo additional evaluations at 6 months, 1 year, 3 and 5 years.
The study will take place at 7 hospitals across Poland. All participating centers have the equipment and skills to perform all necessary procedures in this study. The below centers specialize in the treatment of stomach cancer with many documented years of experience. They are trained in the maintenance of a register, possess the skills to conduct appropriate research analyses and are equipped with a system for assessing the quality of both surgical and oncological treatment.
Details
| Condition | Gastropathy, Gastric Cancer, Gastric Carcinoma, Stomach Cancer, gastric cancers, Stomach Discomfort |
|---|---|
| Treatment | FLOT4 + HIPEC + Surgery, FLOT4 + Surgery |
| Clinical Study Identifier | NCT04597294 |
| Sponsor | Jagiellonian University |
| Last Modified on | 3 September 2021 |
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