title: Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion.
  
  
  METHODS
  The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm.
  
  
  CONCLUSIONS
  The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on patient-reported, rather than disease-orientated, outcomes. Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS.
  
  
  BACKGROUND
  The trial was registered with Current Controlled Trials (registration number: ISRCTN12376468) on 10 July 2012.
authors.forename: Douglas
authors.initials: D
authors.lastname: Adamson
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.forename: Annmarie
authors.initials: A
authors.lastname: Nelson
authors.forename: Chris
authors.initials: C
authors.lastname: Hurt
authors.forename: Lisette
authors.initials: L
authors.lastname: Nixon
authors.forename: Jim
authors.initials: J
authors.lastname: Fitzgibbon
authors.forename: Tom
authors.initials: T
authors.lastname: Crosby
authors.forename: John
authors.initials: J
authors.lastname: Staffurth
authors.forename: Mim
authors.initials: M
authors.lastname: Evans
authors.forename: Noreen Hopewell
authors.initials: NH
authors.lastname: Kelly
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.forename: Gareth
authors.initials: G
authors.lastname: Griffiths
authors.affiliation: Marie Curie Palliative Care Research Centre, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, 1st Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Anthony.Byrne2@wales.nhs.uk.
authors.forename: Anthony
authors.initials: A
authors.lastname: Byrne
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003679:Deglutition; D003680:Deglutition Disorders / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D018450:Disease Progression; D019583:Dose Fractionation, Radiation; D004938:Esophageal Neoplasms / Q000150:complications / Q000191:economics / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D017048:Health Care Costs; D006801:Humans; D008670:Metals / Q000191:economics; D010166:Palliative Care / Q000191:economics / Q000379:methods*; D018579:Patient Selection; D010865:Pilot Projects; D011474:Prosthesis Design; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D012107:Research Design; D018401:Sample Size; D015607:Stents / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D008670:Metals