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

RecruitingPhase 3Ages 18 Years - 75 YearsAllJagiellonian University
NCT04597294 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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. Exclusion Criteria: * No clear histopathological confirmation of gastric cancer. * Age \> 75 years. * Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale). * Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic). * Pregnancy and lactation. * Refusal to participate or an inability to provide written consent. * Coexisting cancer in another location. * Systemic treatment or radiotherapy for another cancer. * Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons. * Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
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What it tests

  • FLOT + HIPEC + Surgery
  • FLOT + Surgery
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Where

1 site
Department of General, Oncological, Gastroenterological Surgery and Transplantology
Krakow, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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