Abstract
BackgroundStage 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/designSABRTooth 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.DiscussionTo 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.Trial registrationcontrolled-trials.com ISRCTN13029788
Highlights
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
To know whether Stereotactic ablative radiotherapy (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 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
Summary
To know whether SABR is a better, equivalent or inferior alternative to surgery for higher risk patients is a key question in lung cancer. The primary aim of this feasibility study is to demonstrate that, over 21 months, enough patients can be randomised from 6 centres to indicate that a phase III trial recruiting 690 patients over 5 years in 20 UK centres would be feasible. The multiple secondary and exploratory endpoints will help determine the most optimum recruitment and data collection strategies and help optimise the design of a future phase III trial where the key aims would be to show NI of SABR to surgery and determine the relative costs of the two treatments and their effects on quality of life. Other studies comparing SABR to surgery have closed early due to poor recruitment, and the SABRTooth trial is a pragmatic study based on everyday practice in hospitals managing lung cancer. JB and JH developed the qualitative aspects of the study and provided qualitative and methodological advice for the study; JB conducted the feedback interviews
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