About this trial
The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80
Hystologicaly proven gastric adenocarcinoma
ECOG status 0-1
Written consent to participate in the study
Disqualifiers
Pregnancy/breastfeeding
ECOG status 2-4
Concomitant malignancy
Mitomycin and/or Cisplatin hypersensitivity
Trial population
The study population will consist of adult patients receiving care at oncological centers in Ukraine who meet all predefined eligibility criteria for this study. Investigators include individuals with for which Gastrectomy+HIPEC is considered an accepted or potentially beneficial treatment option according to national and international clinical guidelines. Participants will be recruited from tertiary surgical oncology hospitals and specialized cancer institutes across Ukraine.
Trial design
Cohort
Prospective
Treatments tested in this trial
curative-intent surgery + HIPEC
Procedure/SurgeryParticipants enrolled in this study will undergo curative-intent gastrectomy for gastric cancer, immediately followed by Hyperthermic Intraperitoneal Chemotherapy (HIPEC) performed during the same operative session. Dosage of drugs: mitomycin C 15 mg/m2, cisplatin 75mg/m2. The procedure is conducted according to a standardized protocol in National Cancer Institute
Treatment groups
Trial outcomes
Primary outcomes
Peritoneal recurrence rate
Number of patients developed peritoneal recurence
Secondary outcomes
Distant recurrence rate
Time from diagnosis to distant reccurence
Intraperitoneal chemotherapy complications rate
Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)
Postoperative complications rate
Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)
5-years overall survival
5-years overall survival
Sponsors and contacts
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