title: Protocol for the CONVERT trial-Concurrent ONce-daily VErsus twice-daily RadioTherapy: an international 2-arm randomised controlled trial of concurrent chemoradiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status.
abstract: BACKGROUND
  Concurrent ONce-daily VErsus twice-daily RadioTherapy (CONVERT) is the only multicentre, international, randomised, phase III trial open in Europe and Canada looking at optimisation of chemoradiotherapy (RT) in limited stage small cell lung cancer (LS-SCLC). Following on from the Turrisi trial of once-daily versus twice-daily (BD) concurrent chemoradiotherapy, there is a real need for a new phase III trial using modern conformal RT techniques and investigating higher once-daily radiation dose. This trial has the potential to define a new standard chemo-RT regimen for patients with LS-SCLC and good performance status.
  
  
  METHODS
  447 patients with histologically or cytologically proven diagnosis of SCLC were recruited from 74 centres in eight countries between 2008 and 2013. Patients were randomised to receive either concurrent twice-daily RT(45 Gy in 30 twice-daily fractions over 3 weeks) or concurrent once-daily RT(66 Gy in 33 once-daily fractions over 6.5 weeks) both starting on day 22 of cycle 1. Patients are followed up until death. The primary end point of the study is overall survival and secondary end points include local progression-free survival, metastasis-free survival, acute and late toxicity based on the Common Terminology Criteria for Adverse Events V.3.0, chemotherapy and RTdose intensity.
  
  
  BACKGROUND
  The trial received ethical approval from NRES Committee North West-Greater Manchester Central (07/H1008/229). There is a trial steering committee, including independent members and an independent data monitoring committee. Results will be published in a peer-reviewed journal and presented at international conferences.
  
  
  BACKGROUND
  ISRCTN91927162; Pre-results.
authors.affiliation: Manchester Academic Health Science Centre, Institute of Cancer Sciences, Manchester Cancer Research Centre (MCRC), The University of Manchester, Manchester, UK Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Corinne
authors.identifier: http://orcid.org/0000-0001-5617-9781
authors.initials: C
authors.lastname: Faivre-Finn
authors.affiliation: Manchester Academic Health Science Centre Trials Coordination Unit (MAHSC-CTU), The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Falk
authors.affiliation: Manchester Academic Health Science Centre Trials Coordination Unit (MAHSC-CTU), The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Linda
authors.initials: L
authors.lastname: Ashcroft
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Bewley
authors.affiliation: Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Lorigan
authors.affiliation: Department of Oncology, University College London Hospitals NHS Foundation Trust, London, UK.
authors.forename: Elena
authors.initials: E
authors.lastname: Wilson
authors.affiliation: Radiotherapy Trials Quality Assurance Team, Mount Vernon Hospital, Northwood, UK.
authors.forename: Nicki
authors.initials: N
authors.lastname: Groom
authors.affiliation: St James' Institute of Oncology, Leeds, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Snee
authors.affiliation: Institut de Cancérologie Lucien Neuwirth, Saint-Priest en Jarez, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Fournel
authors.affiliation: Department of Medical Oncology, Catalan Institute of Oncology, L'Hospitalet, Barcelona, Spain.
authors.forename: Felipe
authors.initials: F
authors.lastname: Cardenal
authors.affiliation: Department of Radiation Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada.
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.affiliation: Manchester Academic Health Science Centre, Institute of Cancer Sciences, Manchester Cancer Research Centre (MCRC), The University of Manchester, Manchester, UK Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Blackhall
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059248:Chemoradiotherapy / Q000379:methods*; D002985:Clinical Protocols; D019583:Dose Fractionation, Radiation; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D055752:Small Cell Lung Carcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
keywords: CHEMOTHERAPY