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14 March 2010
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| [ Print-friendly version ] |
| Cancer of the oesophagus or gastricus: new assessment of the technology of endosonography |
| ISRCTN | ISRCTN01444215 |
| ClinicalTrials.gov identifier | NCT00629863 |
| Public title | Cancer of the oesophagus or gastricus: new assessment of the technology of endosonography |
| Scientific title | |
| Acronym | COGNATE |
| Serial number at source | HTA 01/01/03 |
| Study hypothesis |
What is the role of Endoscopic UltraSound (EUS) in the staging and subsequent management of patients with gastric and oesophageal cancer?
Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/07/2009 to 31/01/2010. |
| Ethics approval | Multicentre Research Ethics Committee (MREC), approved on 14/06/2004 (ref: 04/MRE10/10) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cancer of the oesophagus or gastricus |
| Participants - 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 |
| Participants - exclusion criteria |
1. World Health Organisation (WHO) status three or above
2. Patients with metastatic disease 3. Unfit for surgery |
| Anticipated start date | 01/02/2004 |
| Anticipated end date | 31/01/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 700 |
| Interventions |
Please note that, as of 15/09/2008, the anticipated end date of this trial has been updated from 31/01/2009 to 31/07/2009 (Recruitment phase completed, in follow-up).
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 |
| Primary outcome measure(s) |
Primary outcome measure as of 16/09/2008:
Survival, recorded until the end of trial Previous primary outcome measure: Survival |
| Secondary outcome measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Angela Gliddon |
| Address |
Bangor University
Normal Site Bangor |
| City/town | Gwynedd |
| Zip/Postcode | LL57 2PZ |
| Country | United Kingdom |
| Tel | +44 (0)1248 382224 |
| a.e.gliddon@bangor.ac.uk | |
| Sponsor | Bangor University (UK) |
| Address |
Brigantia Building
Penrallt Road |
| City/town | Bangor |
| Zip/Postcode | LL57 2AS |
| Country | United Kingdom |
| Sponsor website: | http://www.bangor.ac.uk |
| Date applied | 19/02/2004 |
| Last edited | 06/08/2009 |
| Date ISRCTN assigned | 20/02/2004 |
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