ALTG 15/001 SABR-OS: A randomised phase II trial to test the feasibility of randomising patients with peripheral stage I non-small cell lung cancer to either Stereotactic Ablative Radiotherapy (SABR) Or Surgery (previously ALTG 12/005 Surgery vs SABR)
This trial was initially submitted as an international collaborative group phase II study titled SABRTOOTH, however, during 2014 it was recognised that, due to differences in the timing of funding and governance between the UK and Australia, a standalone Australian protocol would need to be developed. As a result, the SABR-OS phase II study was approved for development by the TROG Scientific committee in February 2015 (with ALTG collaboration) and a grant application was submitted to the NHMRC and funding partners in March 2015. It is anticipated that the SABRTOOTH and SABR-OS trials will proceed to a joint international phase III trial.
This trial aims to assess the feasibility of recruiting patients, with histologically confirmed peripheral stage I NSCLC who are at higher risk of mortality and morbidity after surgery, into trial that randomises between multi-fraction Stereotactic Ablative Body Radiotherapy (SABR) and surgery (lobectomy or sub-lobar resection). Disease free and overall survival, toxicity and selected patient-reported outcomes will be assessed as secondary endpoints. A sub study looking at economic evaluation and a study of patient preferences using Discrete Choice Experiment (DCE) will also be included in the protocol.
This study is currently under development and aims to start the 3 year recruitment phase of 72 participants in April 2016.