Condition category
Cancer
Date applied
19/02/2004
Date assigned
20/02/2004
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Angela Gliddon

ORCID ID

Contact details

Bangor University
Normal Site
Bangor
Gwynedd
LL57 2PZ
United Kingdom
+44 (0)1248 382224
a.e.gliddon@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00629863

Protocol/serial number

HTA 01/01/03

Study information

Scientific title

Cancer of the oesophagus or gastricus: new assessment of the technology of endosonography

Acronym

COGNATE

Study hypothesis

What is the role of Endoscopic UltraSound (EUS) in the staging and subsequent management of patients with gastric and oesophageal cancer?

Ethics approval

Multicentre Research Ethics Committee (MREC), 14/06/2004, ref: 04/MRE10/10

Study design

Randomised controlled 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

Cancer of the oesophagus or gastricus

Intervention

Patients will be randomised to receive EUS or not after standard staging investigations. The standard staging algorithm has been selected on the basis of most common current practice identified by the Scottish Audit of Gastro-Oesophageal Cancer (SAGOC). In the EUS group a decision will be made after the EUS investigation to allocate the patients to one of the three treatment groups. Allocation will be based on the results of standard investigations in the control group.

The three treatment groups are:
1. Patients thought to have mucosal tumours - these will be treated with Endoscopic Mucosal Resection (EMR) and the surrounding mucosa ablated
2. Patients with tumours which are thought to be resectable - these will be treated with surgery and neo-adjuvant chemotherapy
3. Patients with advanced localised disease in whom it is not thought that a complete resection is possible - such patients will be treated using a multi-modality approach. In patients with gastric cancers this may involve palliative surgery

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary outcome measure as of 16/09/2008:
Survival, recorded until the end of trial

Previous primary outcome measure:
Survival

Secondary outcome measures

Secondary outcome measures as of 16/09/2008:
1. Treatment selection
2. Complete resection rate
3. Quality of life, assessed using the Euroqol EQ-5D and Functional Assessment of Cancer Therapy (FACT1 and FACT2) after 1, 3, 6, 12, 18, 24 and 36 months after randomisation
4. Health resource utilisation. Collection of clinical data on treatment, primary and secondary care use, drug use, etc will be carried out until the end of trial.

Previous secondary outcome measures:
1. Treatment selection
2. Complete resection rate
3. Quality of life
4. Health resource utilisation

Overall trial start date

01/02/2004

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with T1 tumors localised to the gastric or oesophageal mucosa who may benefit from endoscopic treatment
2. Patients with a range of tumours whom Endoscopic UltraSounds (EUS) may identify either as likely to benefit from 'curative' surgery or likely to have residual disease after major surgery with its attendant risks
3. Patients with T3 or T4 tumours whom EUS may identify as likely to benefit from multi-modal treatment or not

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

1. World Health Organisation (WHO) status three or above
2. Patients with metastatic disease
3. Unfit for surgery

Recruitment start date

01/02/2004

Recruitment end date

31/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bangor University
Gwynedd
LL57 2PZ
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

Brigantia Building
Penrallt Road
Bangor
LL57 2AS
United Kingdom

Sponsor type

University/education

Website

http://www.bangor.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24034150

Publication citations

Additional files

Editorial Notes

On 15/09/2008 the overall trial end date was changed from 31/01/2009 to 31/07/2009. On 11/05/2009 the overall trial end date was changed from 31/07/2009 to 31/01/2010.