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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable oesophageal adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Treatments: Capecitabine; Cisplatin; Epirubicin

Criteria

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.