Actively Recruiting
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Led by Jagiellonian University · Updated on 2024-03-06
600
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological confirmation of gastric cancer
- Age between 18 and 75 years
- Advanced gastric cancer classified as cT3 or cT4a with nodal status N0 to N3b
- No distant metastases detected by CT scans of chest, abdomen, and pelvis (cM0)
- Provided written informed consent to participate in the study
You will not qualify if you...
- Lack of clear histopathological confirmation of gastric cancer
- Age over 75 years
- Poor general health with Performance Status 3 or higher on ECOG/WHO scale
- Previous abdominal surgery other than laparoscopic cholecystectomy or appendectomy
- Pregnancy or breastfeeding
- Refusal or inability to give written consent
- Presence of another active cancer
- Prior systemic treatment or radiotherapy for another cancer
- Dysphagia requiring surgery before starting neoadjuvant treatment or urgent surgery indications
- Ineligibility for perioperative FLOT chemotherapy as determined by a specialist team
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of General, Oncological, Gastroenterological Surgery and Transplantology
Krakow, Lesser Poland Voivodship, Poland, 30-688
Actively Recruiting
Research Team
P
Piotr Richter, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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