title: The SABRTooth feasibility trial protocol: a study to determine the feasibility and acceptability of conducting a phase III randomised controlled trial comparing stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I non-small cell lung cancer (NSCLC) considered to be at higher risk of complications from surgical resection.
abstract: BACKGROUND
  Stage I non-small cell lung cancer (NSCLC) is potentially curable, and surgery is considered to be the standard of care for patients with good performance status and minimal co-morbidity. However, a significant proportion of patients with stage I NSCLC have a poorer performance status and significant medical co-morbidity that make them at higher risk of morbidity and mortality from surgery. Stereotactic ablative radiotherapy (SABR), which uses modern radiotherapeutic techniques to deliver large doses of radiation, has shown superiority over conventional radiotherapy in terms of local control and toxicity and is a standard of care for patients with stage I NSCLC who are at too high risk for surgery. However, it is not known whether surgery or SABR is the most effective in patients with stage I NSCLC who are suitable for surgery but are less fit and at higher risk surgical complications. Previous randomised studies have failed to recruit in this setting, and therefore, a feasibility study is required to see whether a full randomised control trial would be possible.
  
  
  METHODS
  SABRTooth is a UK-based, multi-centre, open-label, two-group individually (1:1) randomised controlled feasibility study in patients with peripheral stage I NSCLC considered to be at higher risk from surgical resection. The study will assess the feasibility of conducting a definitive large-scale phase III trial. The primary objective is to assess recruitment rates to provide evidence that, when scaled up, recruitment to a large phase III trial would be possible; the target recruitment being 54 patients in total, over a 21-month period. There are multiple secondary and exploratory objectives designed to explore the optimum recruitment and data collection strategies to help optimise the design of a future phase III trial.
  
  
  CONCLUSIONS
  To know whether SABR is a better, equivalent or inferior alternative to surgery for higher risk patients is a key question in lung cancer. Other studies comparing SABR to surgery have closed early due to poor recruitment, and therefore, the SABRTooth feasibility study has been designed around the UK National Health Service (NHS) cancer pathway incorporating many design features in order to maximise recruitment for a future definitive phase III trial.
  
  
  BACKGROUND
  controlled-trials.com ISRCTN13029788.
authors.affiliation: Department of Clinical Oncology, Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, Beckett Street, Leeds, LS9 7TF UK.
authors.forename: M P
authors.initials: MP
authors.lastname: Snee
authors.affiliation: Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, 71-75 Clarendon Road, Leeds, LS2 9PH UK.
authors.forename: L
authors.initials: L
authors.lastname: McParland
authors.affiliation: Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, 71-75 Clarendon Road, Leeds, LS2 9PH UK.
authors.forename: F
authors.initials: F
authors.lastname: Collinson
authors.affiliation: Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, 71-75 Clarendon Road, Leeds, LS2 9PH UK.
authors.forename: C M
authors.initials: CM
authors.lastname: Lowe
authors.affiliation: Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, 71-75 Clarendon Road, Leeds, LS2 9PH UK.
authors.forename: A
authors.initials: A
authors.lastname: Striha
authors.affiliation: Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals and University of Nottingham, Hucknall Rd, Nottingham, NG5 1PB UK.
authors.forename: D R
authors.initials: DR
authors.lastname: Baldwin
authors.affiliation: School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, Edgbaston B15 2TT UK.
authors.forename: B
authors.initials: B
authors.lastname: Naidu
authors.affiliation: Department of Clinical Oncology, Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, Beckett Street, Leeds, LS9 7TF UK.|Leeds Institute of Cancer and Pathology, Faculty of Medicine and Health, University of Leeds, Beckett Street, Leeds, LS9 7TF UK.
authors.forename: D
authors.initials: D
authors.lastname: Sebag-Montefiore
authors.affiliation: Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, 71-75 Clarendon Road, Leeds, LS2 9PH UK.
authors.forename: W M
authors.initials: WM
authors.lastname: Gregory
authors.affiliation: Leeds Institute of Health Sciences, Faculty of Medicine and Health, University of Leeds, 101 Clarendon Rd, Leeds, LS2 9LJ UK.
authors.forename: J
authors.initials: J
authors.lastname: Bestall
authors.affiliation: Leeds Institute of Health Sciences, Faculty of Medicine and Health, University of Leeds, 101 Clarendon Rd, Leeds, LS2 9LJ UK.
authors.forename: J
authors.initials: J
authors.lastname: Hewison
authors.affiliation: Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, 71-75 Clarendon Road, Leeds, LS2 9PH UK.
authors.forename: S
authors.initials: S
authors.lastname: Hinsley
authors.affiliation: Department of Clinical Oncology, Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, Beckett Street, Leeds, LS9 7TF UK.
authors.forename: K
authors.initials: K
authors.lastname: Franks
keywords: Feasibility; Lung cancer; NSCLC; Radiotherapy; Randomised; SABR; Stereotactic; Surgery