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

Not Applicable

Completed

• Conditions: Cancer of the oesophagus or gastricus; Cancer; Malignant neoplasm of other or ill-defined digestive organs

• Registration Number: ISRCTN01444215
• Lead Sponsor: Bangor University (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-02-20
• Study Completion: 2010-01-31
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary outcome measure as of 16/09/2008:<br> Survival, recorded until the end of trial<br><br> Previous primary outcome measure:<br> Survival<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary outcome measures as of 16/09/2008:<br> 1. Treatment selection<br> 2. Complete resection rate<br> 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<br> 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.<br><br> Previous secondary outcome measures:<br> 1. Treatment selection<br> 2. Complete resection rate<br> 3. Quality of life<br> 4. Health resource utilisation<br>