Status:
COMPLETED
ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study
Lead Sponsor:
Lisette Nixon
Conditions:
Oesophageal Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The single most distressing symptom for more than 70% of patients with oesophageal cancer is difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This causes severe restr...
Detailed Description
The primary objective of the study is to assess the impact of radiotherapy in addition to self-expanding metal stent (SEMS) placement on time to progression of patient-reported dysphagia in a patient ...
Eligibility Criteria
Inclusion
- Histological confirmation of oesophageal carcinoma excluding small cell histology
- Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
- Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
- Age 16 years or over
- Discussion and treatment decision for stent placement made by an upper GI multi-disciplinary team
- Clinician assessment of ability to attend for radiotherapy
- Expected survival of at least 12 weeks
- Written informed consent
- Patient has completed baseline Quality of Life Questionnaires (please note, as a minimum patients must have completed OG25)
Exclusion
- Histology of small cell carcinoma type
- Tumour length of greater than 12 cm
- Tumour growth within 2 cm of the upper oesophageal sphincter
- Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
- Presence of a tracheo-oesophageal fistula
- Presence of a pacemaker in proposed radiotherapy field
- Previous radiotherapy to the area of the proposed radiotherapy field
- Planned endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period
- Female patient who is pregnant
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01915693
Start Date
October 1 2013
End Date
November 1 2018
Last Update
June 4 2019
Active Locations (17)
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1
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
2
Doncaster Royal Infirmary
Doncaster, England, United Kingdom, DN2 5LT
3
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
4
George Eliot Hospital
Nuneaton, England, United Kingdom, CV10 7DJ