A randomised controlled trial comparing standard chemotherapy followed by resection versus Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy followed by resection in patients with resectable adenocarcinoma of the oesophagus

Medical Research Council (MRC) (UK)0 sites897 target enrollmentAugust 3, 2004

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Resectable adenocarcinoma of the oesophagus or oesophago-gastric junction
Sponsor: Medical Research Council (MRC) (UK)
Enrollment: 897
Status: Completed
Last Updated: 4 years ago

Registry

who.int

Start Date

August 3, 2004

End Date

November 1, 2010

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical Research Council (MRC) (UK)

•1\. Histologically verified adenocarcinoma of the oesophagus or type 1 and type 2 adenocarcinoma of the oesophago\-gastric junction
•2\. Adenocarcinoma as above, which includes disease staged as T1 N1, T2 N1, T3 N0, and T3 N1 as assessed by spiral computed tomography (CT) or endoscopic ultrasound. T4 tumours that involve only the diaphragm or crura as well as T4 tumours invading the mediastinal pleura only.
•3\. Tumours with nodal disease (N1\) affecting the origin of the left gastric and splenic artery with the coeliac axis (hitherto staged as M1a)
•4\. World Health Organisation (WHO) performance status 0 or 1
•5\. Proven respiratory cardiac, hepatic, renal and haematological function to the following levels: forced expiratory volume in 1 second (FEV1\) \>1\.5 litres; cardiac ejection fraction \>50% of normal echocardiography; liver function tests not more than 1\.5 x normal; glomerular filtration rate \=60 ml/min; white blood cell count \>3 x 10^9/l; platelets \>100 x 10^9/l (from the time diagnosis of cancer was first suspected).
•6\. Written informed consent