Condition category
Cancer
Date applied
20/04/2006
Date assigned
18/05/2006
Last edited
05/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Tom Crosby

ORCID ID

Contact details

Velindre Hospital
Whitchurch
Cardiff
CF14 2TL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00509561

Protocol/serial number

WCTU01

Study information

Scientific title

A randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

Acronym

SCOPE 1

Study hypothesis

Patients with histologically confirmed carcinoma of the oesophagus, squamous cell or adenocarcinoma, (considered suitable for definitive chemoradiation by an accredited multi-disciplinary team [MDT] including a specialist upper gastrointestinal [GI] surgeon), will be randomised to receive definitive chemoradiation treatment (CRT) with or without cetuximab.

On 11/02/2009 the overall trial start and end dates were amended. The initial dates at the time of registration were:
Initial overall trial start date: 01/06/2007
Initial overall trial end date: 01/06/2012
All other changes to this record can be found in the relevant field under the update date of 11/02/2009.

Ethics approval

Research Ethics Committee for Wales gave multicentre approval on 17/04/2007

Study design

Two-arm open randomised phase II/III trial with a 1:1 randomisation ratio

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at: http://www.wctu.org.uk/scopedocs.htm

Condition

Oesophageal cancer

Intervention

Control arm: chemoradiation
Experimental arm: chemoradiation plus cetuximab

Intervention type

Drug

Phase

Phase II/III

Drug names

Cisplatin, capecitabine, radiation therapy, cetuximab

Primary outcome measures

Phase II: treatment failure
Phase III: overall survival

Secondary outcome measures

Phase II:
1. Toxicity
2. Feasibility

Phase III:
1. Toxicity
2. Health economics
3. Quality of life
4. Quality assurance

Overall trial start date

07/02/2008

Overall trial end date

01/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Amended 11/02/2009:
The following points of the below criteria have been amended as follows:
2. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell, or undifferentiated) or Siewert type 1 tumour of the gastro-oesophageal junction (GOJ) or Siewert Type 2 with no more than 2 cm mucosal extension into the stomach
3. Tumours staged with endoscopic ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1-4N0-1 confirming localised, non-metastatic disease
7. Adequate cardio-respiratory function for definitive CRT. (Echo or multiple-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1) greater than 1 litre)
8. Adequate renal function for definitive CRT (renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min
9. Written informed consent to participate in the trial

Initial information at time of registration:
1. Patients older than 18 years of age who have been selected to receive potentially curative definitive chemo-radiation
2. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma or squamous cell) or Siewert type 1 tumour of the gastro-oesophageal junction (GOJ)
3. Tumours staged with endorectal ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1-4N0-1 confirming localised, non-metastatic disease
4. Total disease length (primary tumour and lymph nodes) less than 10 cm defined by EUS
5. World Health Organization (WHO) performance status 0 or 1
6. Patients physically and psychologically fit and willing to receive definitive chemoradiation with or without cetuximab
7. Adequate cardio-respiratory function for definitive CRT. Echo or multiple-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1) greater than 1 litre, renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min).
8. Written informed consent to participate in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

440 (420 as of 11/02/2009)

Participant exclusion criteria

Amended 11/02/2009:
The following points of the below criteria have been amended as follows:
3. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation or may compromise survival

Initial information at time of registration:
1. Patients who have had previous treatment for oesophageal carcinoma
2. Patients with metastatic disease i.e. M1a/coeliac nodes or M1b
3. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation
4. Patients with significant (greater than 2 cm) extension of tumour into the stomach

Recruitment start date

07/02/2008

Recruitment end date

06/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Velindre Hospital
Cardiff
CF14 2TL
United Kingdom

Sponsor information

Organisation

Velindre NHS Trust (UK)

Sponsor details

Velindre Hospital
Whitchurch
Cardiff
CF14 2TL
United Kingdom

Sponsor type

Government

Website

http://www.wales.nhs.uk/sites3/home.cfm?orgid=34

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C20177/A6386)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes