Introduction Oesophageal cancer patients often experience dysphagia due to the blockage of the gullet by the tumour, resulting in severe restrictions on food intake, physical activity, social functioning and quality of life. One of the more effective treatments to improve swallowing is the insertion of a metal stent (SEMS), which then self expands to open up the gullet. The addition of radiotherapy may also help to improve the problems causes by dysphagia and provide an additional survival benefit.
Aims and Methods To add radiotherapy to SEMS and examine the impact on: i) duration of improvement of swallow; ii) quality of life; iii) survival. A pragmatic, randomised controlled trial of external beam radiotherapy plus SEMS versus SEMS alone in 396 patients with oesophageal cancer. Radiotherapy will be given as an outpatient either as five treatments over one week, or ten treatments over two weeks. Questionnaires assessing quality of life and cost effectiveness will be completed at weeks two, four, eight and twelve and then monthly for up to one year. Semi-structured interviews will be held with: i) trial participants to explore their experiences while on the trial; ii) patients who decide not to take part in the trial to explore reasons for non-consent.
Results This trial will provide data on the time to progression of dysphagia, quality of life, morbidity and re-intervention rates, survival, patient attitude to treatment and cost-effectiveness of the treatment.
Conclusion Achieving funding for large scale trials capable of answering important symptom control questions is feasible using a pragmatic approach.
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