ROCS

Radiotherapy after Oesophageal Cancer Stenting.

Background

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 restrictions on food intake, physical activity, social functioning and overall quality of life. Amongst the more effective treatments for improving swallowing, is the insertion of a metal stent across the blocked part, which then self-expands to open up the gullet (Self Expanding Metal Stent). The addition of radiotherapy may help to improve the problems caused by dysphagia and provide an additional survival benefit.

Study aim

The purpose of this study is to test the impact of adding radiotherapy to a stent on:

• the length of time swallow remains improved for
• quality of life
• survival.

The ROCS study is addressing a specific gap in the evidence base for sustained palliation in advanced oesophageal cancer. The study will assess the impact of radiotherapy on quality of life and survival when used in addition to self-expanding metal stent as treatment for difficulty in swallowing (dysphagia).

Recruitment

220 patients will be randomised to receive either a stent alone or a stent with radiotherapy. Patients can be randomised before or after their stent has been inserted, but randomisation before stent insertion will provide more useful data and is encouraged. The radiotherapy will be given as an outpatient either as five treatments (one per day) over one week, or ten treatments over two weeks. Questionnaires will be completed before treatment, one week post stent and four weekly for up to one year to assess quality of life and cost effectiveness. Brief phone calls to participants will be carried out half way between the scheduled four weekly follow up visits to administer a short questionnaire containing three questions.

Constraints to recruitment

Burdens associated with study participation are not easily identified but following research practitioners have collected large amounts of anecdotal data about why patients choose not to participate in the study. Reasons cited for non-consenting have included:

• Too much going on at the time of recruitment
• Patients are scared
• Patient is too stressed to consider anything more than their immediate situation
• Too unwell
• Want to enjoy whatever time they have left
• Do not want to have radiotherapy
• Extra burden on family
• Family input.

Eligibility criteria for participation

Patients will be eligible to take part in the trial if they have oesophageal cancer, are in need of a stent because of dysphagia, are aged 16 years or older, have been clinically assessed to be able to receive radiotherapy, have an expected survival of at least 12 weeks and are able to give written informed consent.

Study design

Patients will be eligible to take part in the trial if they have oesophageal cancer, are in need of a stent because of dysphagia, are aged 16 years or older, have been clinically assessed to be able to receive radiotherapy, have an expected survival of at least 12 weeks and are able to give written informed consent.

220 patients will be randomised to receive either a stent alone or a stent with radiotherapy. Patients can be randomised before or after their stent has been inserted, but randomisation before stent insertion will provide more useful data and is encouraged. The radiotherapy will be given as an outpatient either as five treatments (one per day) over one week, or ten treatments over two weeks. Questionnaires will be completed before treatment, one week post stent and four weekly for up to one year to assess quality of life and cost effectiveness. Brief phone calls to participants will be carried out half way between the scheduled four weekly follow up visits to administer a short questionnaire containing 3 primary end point questions only. Interviews will be held with trial participants at three time points to explore their experiences while on the trial. Interviews will also be held with patients who do not consent to take part in the trial to explore their reasons for non-consent.

Involving the public and patients

The ROCS study has two research partners as members of the Trial Management Group. They have direct input into the day-to-day running and management of the trial. We have also used their expertise when writing and reviewing patient information documents (i.e. patient information sheet and consent forms).