Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Recruiting now · Phase 3
Conditions studied: Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT04597294
- Run by
- Jagiellonian University
- People needed
- 600
- Starts
- 2021-08-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-03-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Department of General, Oncological, Gastroenterological Surgery and Transplantology — Krakow, Lesser Poland Voivodship, Poland (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.