Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
- 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
- No previous chemotherapy, radiotherapy or other investigational drug treatment for
- 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.
- 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
- Patients with disease in any of the following areas on the basis of CT scan and/or
- 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.