Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
NCT ID: NCT07313579
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-12-01
2035-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prophylactic cohort (T4a/T4b/cyt+)
The cohort consists of individuals undergoing gastrectomy along with HIPEC.
curative-intent surgery + HIPEC
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
Low PCI cohort (PCI<7)
Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC
curative-intent surgery + HIPEC
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
Interventions
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curative-intent surgery + HIPEC
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
Eligibility Criteria
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Inclusion Criteria
2. Hystologicaly proven gastric adenocarcinoma
3. ECOG status 0-1
4. Written consent to participate in the study
5. Medically and technically operable gastric tumor
6. Only T4a or T4b tumours with any peritoneal cytology status
7. Cytologically positive peritoneal washings (cyt+) with any T and N criteria
8. Adequate haemopoetic, renal and hepatic function (Hb \> 120, PLT \> 150\*10\^9/l, ALT \< 60, AST \<40, total bilirubin \< 21 µmol/l, Creatinine clearance (male - 90-140, female - 80-130 ml/min)
Exclusion Criteria
2. ECOG status 2-4
3. Concomitant malignancy
4. Mitomycin and/or Cisplatin hypersensitivity
5. Uncontrollable chronic diseases
6. Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years.
7. Presence of metastases other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes)
8. History of allergic reactions associated with cisplatin and Mitomycin C
9. Patients with psychiatric illness/social situations with impaired compliance
10. •Refusal to participate
18 Years
80 Years
ALL
No
Sponsors
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Ukrainian Society of Clinical Oncology
OTHER
Responsible Party
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Oleksii Dobrzhanskiy
Physician
Locations
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National Cancer Institute (NCI)
Kyiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24999/2025
Identifier Type: -
Identifier Source: org_study_id
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