SABRTOOTH: A randomised controlled feasibility study of 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
- Kevin N. Franks1,2,13⇑,
- Lucy McParland3,13,
- Joanne Webster3,
- David R. Baldwin4,
- David Sebag-Montefiore1,2,3,
- Matthew Evison5,
- Richard Booton5,
- Corinne Faivre-Finn6,
- Babu Naidu7,
- Jonathan Ferguson8,
- Clive Peedell8,
- Matthew E.J. Callister9,
- Martyn Kennedy9,
- Jenny Hewison10,
- Janine Bestall10,
- Walter M. Gregory3,
- Peter Hall11,
- Fiona Collinson3,
- Catherine Olivier3,
- Rachel Naylor3,
- Sue Bell3,
- Peter Allen12,
- Andrew Sloss12 and
- Michael Snee1
- 1Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom
- 2Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom
- 3Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom
- 4Nottingham University Hospitals, Nottingham, United Kingdom
- 5Manchester University Hospitals NHS Foundation Trust & University of Manchester, Manchester, United Kingdom
- 6University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom
- 7Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
- 8The James Cook University Hospital, Middlesbrough, United Kingdom
- 9Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom
- 10Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom
- 11Western General Hospital, University of Edinburgh, Edinburgh, United Kingdom
- 12Patient and Public Involvement Representative, Leeds, UK
- 13Joint first authors
- Dr Kevin N Franks, Level 4, Bexley Wing, Leeds Cancer Centre, St James's University Hospital, Beckett Street, Leeds, UK, LS9 7TF. E-mail: kevin.franks{at}nhs.net
Abstract
Objectives Stereotactic Ablative Radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I non-small cell lung cancer (NSCLC). Previous non-randomised evidence supports SABR as an alternative to surgery, but high quality randomised controlled trial (RCT) evidence is lacking. The SABRTooth study aimed to establish whether a UK phase III RCT was feasible.
Design and Methods SABRTooth was a UK multi-centre, randomised controlled feasibility study targeting patients with peripheral stage I NSCLC considered to be at higher-risk of surgical complications. Fifty-four patients were planned to be randomised 1:1 to SABR or surgery. The primary outcome was monthly average recruitment rates.
Results Between July 2015 and January 2017, 318 patients were considered for the study and 205(64.5%) were deemed ineligible. Of 106 assessed as eligible (33.3%), 24 patients (22.6%) were randomised to SABR (n=14) or surgery (n=10). A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery. The average monthly recruitment rate was 1.7 patients against a target of 3. Fifteen patients underwent their allocated treatment, 12 SABR, 3 surgery.
Conclusions We conclude that a phase III RCT randomising higher-risk patients between SABR and surgery is not feasible in the National Health Service (NHS). Patients have pre-existing treatment preferences, which was a barrier to recruitment. A significant proportion of patients randomised to the surgical group declined and chose SABR. SABR remains an alternative to surgery and novel study approaches are needed to define which patients benefit from a non-surgical approach.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Franks has nothing to disclose.
Conflict of interest: Dr. McParland has nothing to disclose.
Conflict of interest: Dr. Webster has nothing to disclose.
Conflict of interest: Dr. Baldwin has nothing to disclose.
Conflict of interest: Dr. Sebag-Montefiore has nothing to disclose.
Conflict of interest: Dr. Evison has nothing to disclose.
Conflict of interest: Dr. Booton has nothing to disclose.
Conflict of interest: Dr. Faivre-Finn has nothing to disclose.
Conflict of interest: Dr. Naidu has nothing to disclose.
Conflict of interest: Dr. Ferguson has nothing to disclose.
Conflict of interest: Dr. Peedell has nothing to disclose.
Conflict of interest: Dr. Callister has nothing to disclose.
Conflict of interest: Dr. Kennedy has nothing to disclose.
Conflict of interest: Dr. Hewison has nothing to disclose.
Conflict of interest: Dr. Bestall has nothing to disclose.
Conflict of interest: Dr. Gregory has nothing to disclose.
Conflict of interest: Dr. Hall has nothing to disclose.
Conflict of interest: Dr. Collinson has nothing to disclose.
Conflict of interest: Dr. Olivier has nothing to disclose.
Conflict of interest: Dr. Naylor has nothing to disclose.
Conflict of interest: Dr. Bell has nothing to disclose.
Conflict of interest: Dr. Allen has nothing to disclose.
Conflict of interest: Dr. Sloss has nothing to disclose.
Conflict of interest: Dr. Snee has nothing to disclose.
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- Received January 20, 2020.
- Accepted May 28, 2020.
- Copyright ©ERS 2020