A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

Inclusion Criteria:

* Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
* No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if \>12 months previously).
* Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (\>3 admissions for infective exacerbation in past 12 months) etc.
* ECOG performance status ≤ 2.
* Age ≥ to 18.
* Life expectancy ≥ 3 months
* Adequate renal, hepatic and bone marrow function
* Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula (see Appendix L).
* Liver function tests:

Bilirubin ≤ 1.0 x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN,Haemoglobin \> 10.0 g/dl, Absolute neutrophil count \>1.5 x 109 /L, Platelet count \> 100 x109/L.

•Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Symptoms or signs of peripheral neuropathy.
* Patients known to have second or third degree heart block.
* Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
* Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
* Pregnant or nursing.
* Female of child-bearing potential, or male partner of female of child bearing potential not taking adequate contraceptive precautions.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial