Randomised trial comparing the efficacy of epirubicin, cisplatin and 5-fluorouracil (FEC) to 5-fluorouracil, methotrexate and adriamycin (FAMTX) in patients with gastric and oesophageal cancer

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2001
INTERVENTION: Patients are randomised to one of two chemotherapy regimens: 1. ECF Regimen: Multi‐drug chemotherapy with epirubicin, cisplatin and 5‐fluorouracil (FEC). Epirubicin and cisplatin repeated every 3 weeks for eight cycles. 5‐Fluorouracil to be given by continuous infusion daily via central line for 21 weeks, stopping the day after the last cycle of cisplatin and epirubicin. 2. FAMTX Regimen: Multi‐drug chemotherapy with methotrexate, adriamycin and 5‐fluorouracil, cycle to be repeated every 28 days for six cycles. CONDITION: Oesophagus, stomach cancer ; Cancer ; Oesophagus, stomach PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Histologically verified locally advanced or metastatic adenocarcinoma or undifferentiated carcinoma of the oesophagus or stomach 2. Bi‐dimensionally measurable disease as assessed by Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or radiography: evaluable disease; non‐evaluable disease 3. No prior chemotherapy or radiotherapy 4. Adequate renal and hepatic function 5. Projected life expectancy of at least 3 months 6. No history of other malignant disease other than adequately treated non‐melanotic skin cancer or in‐situ carcinoma of the uterine cervix 7. No contraindications to treatment protocols
Epistemonikos ID: 2a5e00e2681e85c5fd54a3e276e03e4cf0c269c0
First added on: Aug 21, 2024