Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma

Inclusion criteria

• Age > 18 years.
• Histologically verified adenocarcinoma of the thoracic oesophagus or type 1, 2 and 3 tumours of the oesophagogastric junction (type 1 refers to lower oesophageal, type 2 refers to cardial and type 3 refers to subcardinal cancers).
• AJCC Stage II-III (T2-3 N0-1 M0) (28), as assessed by spiral or multi-slice CT and endoscopic ultrasound, where primary surgery would be considered with curative intent.
• No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
• WHO performance status 0,1 or 2.
• Adequate bone marrow function with platelets > 100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l at the time of study entry.
• Serum bilirubin < 35 mol/l.
• Serum creatinine < 180 mol/l and measured creatinine clearance over 60ml/min.
• No concurrent uncontrolled medical condition.
• No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
• Life expectancy > 3 months.
• Adequate contraceptive precautions if relevant.
• Informed written consent.

Exclusion criteria

• The presence of locally advanced or metastatic disease precluding curative surgical resection (T4 or Stage IV or M1a-b)
• Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
• Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:

• Evidence of liver, lung or other distant metastases
• Para-aortic/coeliac lymphadenopathy > 1cm diameter on CT, > 6mm diameter on EUS
• Invasion of airways, aorta, pericardium, or lung
• New York Heart Association classification Grade III or IV.
• Uncontrolled angina pectoris.
• Pregnancy or breast feeding.
• Impaired renal function with measured creatinine clearance less than 60 ml/min.
• Known malabsorption syndromes.
• Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency.