Prospective randomised phase II clinical trial of epirubicin, cisplatin, continuous infusional 5-fluorouracil (ECF) versus epirubicin, cisplatin and capecitabin (ECX) in patients with advanced gastric cancer

INTERVENTION: 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, cisplatin 60 mg/m^2 on Day 1 by intravenous injection, 5‐FU 200 mg/m^2/day was administrated by continuous infusion on Day 1‐14 of each cycle. Cycle was repeated every 3 weeks. In ECX combination epirubicin 50 mg/m^2 and cisplatin 60 mg/m^2 were administrated on Day 1 by intravenous injection. Capecitabine 825 mg/m^2 twice daily was administrated orally on Day 1‐14. Cycle was repeated every 3 weeks. Treatment was continued until disease progression, unacceptable toxicity occurred or the patient refused further treatment. CONDITION: Advanced gastric cancer ; Cancer ; Malignant neoplasm of stomach PRIMARY OUTCOME: 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 OUTCOME: 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. 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