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Recruiting NCT07313579

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

— Observational Gastric Cancer (GC) HIPEC Peritoneal Metastases From Gastric Cancer Hyperthermic Intraperitoneal Chemoperfusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: curative-intent surgery + HIPEC.
Who it may be relevant to
Registry conditions: Gastric Cancer (GC), HIPEC, Peritoneal Metastases From Gastric Cancer, Hyperthermic Intraperitoneal Chemoperfusion. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ukraine
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

Overview

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.

Detailed description

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).

Interventions

  • Procedure 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

Primary outcome measures

  • Peritoneal recurrence rate [Time frame: From enrolment up to 5 years of follow-up]
Secondary outcome measures (7)
  • Distant recurrence rate [Time frame: Time from diagnosis up to 5 years of follow-up]
  • Intraperitoneal chemotherapy complications rate [Time frame: 30 days after chemotherapy]
  • Postoperative complications rate [Time frame: 30 days after surgery]
  • 5-years overall survival [Time frame: From the time of diagnosis up to 5 years of follow-up]
  • 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 [Time frame: 6 months after treatment completion]
  • Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach [Time frame: 6 months after treatment completion]

Eligibility criteria

Inclusion criteria

  • Age 18-80
  • Hystologicaly proven gastric adenocarcinoma
  • ECOG status 0-1
  • Written consent to participate in the study
  • Medically and technically operable gastric tumor
  • Only T4a or T4b tumours with any peritoneal cytology status
  • Cytologically positive peritoneal washings (cyt+) with any T and N criteria
  • 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

  • Pregnancy/breastfeeding
  • ECOG status 2-4
  • Concomitant malignancy
  • Mitomycin and/or Cisplatin hypersensitivity
  • Uncontrollable chronic diseases
  • Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years.
  • Presence of metastases other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes)
  • History of allergic reactions associated with cisplatin and Mitomycin C
  • Patients with psychiatric illness/social situations with impaired compliance
  • •Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Ukraine · 1 center
  • National Cancer Institute (NCI) — Kyiv

Identifiers

NCT: NCT07313579 · 24999/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗