Advanced gastric cancer Cancer Malignant neoplasm of stomach
Conditions
Interventions
This trial took place at the Institute of Ljubljana (single-centre trial).
Patients were randomised to ECF or ECX chemotherapy group in equal numbers:
ECF consisted of epirubicin 50 mg/m^2, cispla
Sponsors
Ministry of Higher Education, Science and Technology (Slovenia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, age 18 years or older 2. Histologically confirmed advanced gastric cancer 3. Performance status of 0-2 4. Adequate bone marrow function 5. Adequate renal, hepatic function 7. Normal cardiac function 8. Estimated life expectancy more than 3 months
Exclusion criteria
Exclusion criteria: 1. Performance status more than 2 2. Patients not recovered from operation 3. Patients with unresolved intestinal obstruction 4. Malabsorption syndrome 5. Pregnancy 6. Breastfeeding or childbearing potential without using adequate contraception 7. Cardiovascular diseases (New York Heart Association [NYHA] III-IV) 8. Impaired renal function 9. Liver diseases 10. Active hepatitis (hepatitis B, hepatitis C) 11. HIV positive 12. Other active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) The primary and secondary outcomes were assessed at baseline, 3 and 6 months during therapy, then follow-up was performed every 3 months until progression of disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety 2. Progression-free survival (PFS) 3. Overall survival (OS) The primary and secondary outcomes were assessed at baseline, 3 and 6 months during therapy, then follow-up was performed every 3 months until progression of disease. | — |
Countries
Slovenia
Outcome results
None listed