RECRUITINGOBSERVATIONAL
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Age 18-80
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)
Who Should NOT Join This Trial:
1. Pregnancy/breastfeeding
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Age 18-80
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:
1. Pregnancy/breastfeeding
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
Treatments Being Tested
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
Locations (1)
National Cancer Institute (NCI)
Kyiv, Ukraine