Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Recruiting
Phase 3
Interventional Study
Gastric Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 600 (estimated)
- Sponsor
- Jagiellonian University · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
Ex…
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