Actively Recruiting
Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Led by Ukrainian Society of Clinical Oncology · Updated on 2026-01-13
200
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the outcomes of combining hyperthermic intraperitoneal chemoperfusion (HIPEC) with curative-intent gastrectomy in patients who have resectable locally-advanced and limited-metastatic gastric cancer with a low peritoneal cancer index. This study addresses the challenge that surgery combined with systemic chemotherapy or immunotherapy may not always remove microscopic cancer deposits or prevent peritoneal spread, especially in T4 tumors or those with positive peritoneal washings. The goal is to reduce the risk of peritoneal progression by adding HIPEC after surgery. Participants will undergo curative-intent gastrectomy followed immediately by a single dose of HIPEC during the same operation. The HIPEC procedure uses mitomycin C and cisplatin administered according to a standardized protocol. The study groups include patients with T4a or T4b tumors or positive peritoneal cytology, and those with low peritoneal cancer index (less than 7) who receive cytoreduction of visible peritoneal nodules before HIPEC. During the study, participants will be monitored for up to five years to assess the rate of peritoneal recurrence as the primary outcome. Secondary outcomes include distant recurrence rates, complications related to intraperitoneal chemotherapy and surgery within 30 days, overall survival, relapse-free survival over five years, and treatment-related quality of life measured six months after treatment. The study involves follow-up assessments and questionnaires to evaluate these outcomes comprehensively.
CONDITIONS
Brief Title
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Histologically confirmed gastric adenocarcinoma
- ECOG performance status 0 or 1
- Written consent to participate in the study
- Medically and technically operable gastric tumor
- Tumors classified as T4a or T4b with any peritoneal cytology status
- Cytologically positive peritoneal washings with any T and N criteria
- Adequate blood, liver, and kidney function (specific lab value limits)
You will not qualify if you...
- Pregnancy or breastfeeding
- ECOG performance status 2 to 4
- Presence of other active cancers
- Known hypersensitivity to mitomycin or cisplatin
- Uncontrolled chronic diseases
- History of other malignancies (except basal cell skin carcinoma) within the last five years
- Metastases beyond regional or peritoneal areas
- Psychiatric illness or social situations affecting study compliance
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration following surgery
Participants undergo curative-intent gastrectomy followed by a single dose of hyperthermic intraperitoneal chemotherapy (HIPEC) during the same surgery session.
1 surgical procedure with immediate post-operative care
Duration - 30 days after surgery and chemotherapy
Participants are monitored for chemotherapy and surgery-related complications and recovery during the 30 days post-treatment.
Approximately 6 post-operative visits
Duration - Up to 5 years
Participants are followed up to monitor peritoneal and distant recurrence, survival, and quality of life for up to 5 years after treatment.
Regular follow-up visits according to clinical practice
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Kyiv, Ukraine
Actively Recruiting
Research Team
O
Oleksiy Dobrzhanskyi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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