Randomised phase II study of sequentially high dose Methotrexate and Fluorouracil combined with Epirubicin (FEMTX) versus FEMTX plus Cisplatin (FEMTX-P) in advanced gastric cancer

INTERVENTION: Patients are randomised to one of four treatment arms: 1. Arm A: Chemotherapy with FEMTX 2. Arm B: Chemotherapy with FEMTX plus Granulocyte Colony Stimulating Factor (G‐CSF) 3. Arm C: Chemotherapy with FEMTX‐P 4. Arm D: Chemotherapy with FEMTX‐P plus G‐CSF Centres may choose to randomise to Arms A and Arm C only. FEMTX: Chemotherapy with 5‐flourouracil, high‐dose methotrexate and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. FEMTX‐P: Chemotherapy with 5‐flourouracil, high‐dose methotrexate, cisplatinum and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. CONDITION: Oesophagus, Stomach Cancer ; Cancer ; Malignant neopplasm of other or ill‐defined digestive organs PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Aged less than 70 years 2. Histologically confirmed locally advanced and/or metastatic gastric cancer 3. Measurable or evaluable disease 4. Karnofsky status 80‐100 5. Adequate renal, hepatic and bone marrow function