Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01915693
Eligibility Criteria:
Inclusion Criteria:
1. Histological confirmation of oesophageal carcinoma excluding small cell histology
2. Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
3. Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
4. Age 16 years or over
5. Discussion and treatment decision for stent placement made by an upper GI multi-disciplinary team
6. Clinician assessment of ability to attend for radiotherapy
7. Expected survival of at least 12 weeks
8. Written informed consent
9. Patient has completed baseline Quality of Life Questionnaires (please note, as a minimum patients must have completed OG25)
Exclusion Criteria:
1. Histology of small cell carcinoma type
2. Tumour length of greater than 12 cm
3. Tumour growth within 2 cm of the upper oesophageal sphincter
4. Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
5. Presence of a tracheo-oesophageal fistula
6. Presence of a pacemaker in proposed radiotherapy field
7. Previous radiotherapy to the area of the proposed radiotherapy field
8. Planned endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period
9. Female patient who is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01915693
Study Brief:
Protocol Section:
NCT01915693