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.
Several recent studies showed that near-perfect curative-intent R0 surgical technique combined with systemic chemotherapy or even immunotherapy may not always be enough to eliminate microscopic deposits or eliminate peritoneal dissemination in locally advanced gastric cancer or low peritoneal cancer-index (PCI) tumors. The risk of peritoneal dissemination is especially high for T4 tumors, for those with cytologically positive peritoneal washings. Moreover, the risk of peritoneal relapse in low PCI tumors is remarkably high. Combination of surgery and intraperitoneal chemotherapy aims to minimise the risks of the aforementioned peritoneal progression. In the study investigators perform curative surgery followed by single dose of hyperthermic intraperitoneal chemotherapy (HIPEC).
Study Type
OBSERVATIONAL
Enrollment
200
Participants 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
National Cancer Institute (NCI)
Kyiv, Ukraine
RECRUITINGPeritoneal recurrence rate
Number of patients developed peritoneal recurence
Time frame: From enrolment up to 5 years of follow-up
Distant recurrence rate
Time from diagnosis to distant reccurence
Time frame: Time from diagnosis up to 5 years of follow-up
Intraperitoneal chemotherapy complications rate
Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)
Time frame: 30 days after chemotherapy
Postoperative complications rate
Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)
Time frame: 30 days after surgery
5-years overall survival
5-years overall survival
Time frame: From the time of diagnosis up to 5 years of follow-up
5-years relapse-free survival rate
5-years relapse-free survival rate
Time frame: Time from diagnosis up to 5 years of follow-up
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0 (lower score means better outcomes, higher score means worse outcomes)
Time frame: 6 months after treatment completion
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach
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Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (lower score means better outcomes, higher score means worse outcomes)
Time frame: 6 months after treatment completion