Condition category
Cancer
Date applied
23/06/2004
Date assigned
03/08/2004
Last edited
01/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Derek Alderson

ORCID ID

Contact details

University Dept of Surgery
Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00041262

Protocol/serial number

OE05

Study information

Scientific title

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

Acronym

Study hypothesis

Randomised controlled phase III trial to compare pre-operative Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy to standard pre-operative chemotherapy, in patients with resectable adenocarcinoma of the oesophagus.

On 08/02/2011 the overall trial end date was changed from 01/11/2010 to 01/04/2011 and the target number of participants was changed from 1300 to 842.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Resectable adenocarcinoma of the oesophagus or oesophago-gastric junction

Intervention

Patients with resectable adenocarcinoma of the oesophagus will be randomised to receive:
1. Pre-operative Epirubicin, Cisplatin and Xeloda (ECX) chemotherapy
2. Standard pre-operative chemotherapy

Intervention type

Drug

Phase

Phase III

Drug names

Epirubicin, cisplatin, capecitabine, fluorouracil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2004

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

842 (into two groups)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/11/2004

Recruitment end date

01/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

Ian Viney
MRC Centre London
Second Floor
Stephson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://annonc.oxfordjournals.org/content/26/suppl_4/iv117.3.extract

Publication citations

Additional files

Editorial Notes