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

Phase 3

Completed

• Conditions: Resectable adenocarcinoma of the oesophagus or oesophago-gastric junction; Cancer; Malignant neoplasm of oesophagus

• Registration Number: ISRCTN01852072
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

2015 Abstract results in https://doi.org/10.1093/annonc/mdv262.03 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28784312 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-08-03
• Study Completion: 2010-11-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 897

Inclusion Criteria

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

Exclusion Criteria

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration