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

ISRCTN	ISRCTN01444215
DOI	https://doi.org/10.1186/ISRCTN01444215
ClinicalTrials.gov number	NCT00629863
Secondary identifying numbers	HTA 01/01/03

Submission date: 19/02/2004
Registration date: 20/02/2004
Last edited: 20/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-an-ultrasound-during-endoscopy-to-assess-cancer-of-the-oesophagus

Contact information

Dr Angela Gliddon
Scientific

Bangor University
Normal Site
Bangor
Gwynedd
LL57 2PZ
United Kingdom

Phone	+44 (0)1248 382224
Email	a.e.gliddon@bangor.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cancer of the oesophagus or gastricus: new assessment of the technology of endosonography
Study acronym	COGNATE
Study objectives	What is the role of Endoscopic UltraSound (EUS) in the staging and subsequent management of patients with gastric and oesophageal cancer?
Ethics approval(s)	Multicentre Research Ethics Committee (MREC), 14/06/2004, ref: 04/MRE10/10
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2004
Completion date	31/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	700
Key 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
Key exclusion criteria	1. World Health Organisation (WHO) status three or above 2. Patients with metastatic disease 3. Unfit for surgery
Date of first enrolment	01/02/2004
Date of final enrolment	31/01/2010

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Bangor University

Gwynedd
LL57 2PZ
United Kingdom

Sponsor information

Bangor University (UK)
University/education

Brigantia Building
Penrallt Road
Bangor
LL57 2AS
Wales
United Kingdom

Website	http://www.bangor.ac.uk
"ROR"	https://ror.org/006jb1a24

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No
Plain English results			20/01/2022	No	Yes

Editorial Notes

20/01/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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.