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

Royal Marsden NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Adenocarcinoma of Oesophagus

Treatments

Procedure: Surgical resection

Drug: epirubicin, capecitabine, cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00220103

2185

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.