Cancer of the oesophagus or gastricus Cancer Malignant neoplasm of other or ill-defined digestive organs
Conditions
Interventions
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
Sponsors
Bangor University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. World Health Organisation (WHO) status three or above 2. Patients with metastatic disease 3. Unfit for surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 16/09/2008: Survival, recorded until the end of trial Previous primary outcome measure: Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom, Wales
Outcome results
None listed