National Cancer Institute (NCI)
Kyiv, Ukraine
Location status: Recruiting
Location contact
Oleksiy Dobrzhanskyi, MD
CONTACT
Oleksiy Dobrzhanskyi, MD
CONTACT
NCT Number: NCT07313579
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Kyiv, Ukraine
Location status: Recruiting
Oleksiy Dobrzhanskyi, MD
CONTACT
Oleksiy Dobrzhanskyi, MD
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From enrolment up to 5 years of follow-up
Number of patients developed peritoneal recurence
Time frame: Time from diagnosis up to 5 years of follow-up
Time from diagnosis to distant reccurence
Time frame: 30 days after chemotherapy
Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)
Time frame: 30 days after surgery
Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)
Time frame: From the time of diagnosis up to 5 years of follow-up
5-years overall survival
Time frame: Time from diagnosis up to 5 years of follow-up
5-years relapse-free survival rate
Time frame: 6 months after treatment completion
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 (lower score means better outcomes, higher score means worse outcomes)
Contact information is provided by the study sponsor or research team.
Ukrainian Society of Clinical Oncology
Other
Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Acronym: G-PEC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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