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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic cohort (T4a/T4b/cyt+) | The cohort consists of individuals undergoing gastrectomy along with HIPEC. |
| |
| Low PCI cohort (PCI<7) | Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| curative-intent surgery + HIPEC | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peritoneal recurrence rate | Number of patients developed peritoneal recurence | From enrolment up to 5 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Distant recurrence rate | Time from diagnosis to distant reccurence | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oleksiy Dobrzhanskyi, MD | Contact | +380638760185 | alekseydobrzhanskiy@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Recruiting | Kyiv | Ukraine |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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|
| 30 days after chemotherapy |
| Postoperative complications rate | Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5) | 30 days after surgery |
| 5-years overall survival | 5-years overall survival | 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 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) | 6 months after treatment completion |
| Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach | Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (lower score means better outcomes, higher score means worse outcomes) | 6 months after treatment completion |
| D006979 |
| Hyperthermia, Induced |