P1.05-029 SABRTOOTH-A Feasibility Study of SABR Compared to Surgery in Patients with Peripheral Stage I NSCLC Considered to Be at Higher Risk from Surgery

Stereotactic Ablative Radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I NSCLC. Previous non-randomized evidence supports SABR as an alternative to surgery, but high quality randomized control trial (RCT) evidence is lacking due to low recruitment. The UK SABRtooth study aims to see if a large RCT is feasible. The trial management group includes pulmonologists, thoracic surgeons, nurses, patient representatives, oncologists and statisticians. Patients considered at higher-risk of operative mortality and morbidity with a peripheral stage I (<5cm) NSCLC are eligible. Defining “higher-risk” patients considers multiple criteria, but the final decision is left to the individual tumor boards. Equipoise in presenting the two interventions to patients was considered key. Bias is minimized by ensuring the initial approach is by the pulmonologist with subsequent counseling by the research nurse and randomization occurring before consultation with a surgeon or oncologist . Patients who decline the trial or do not proceed with their allocated treatment are invited to take part in qualitative interviews. The trial is open in 4 thoracic oncology centers and their referral units. The aim is to recruit on average 3 patients/month to demonstrate that a phase III RCT would be feasible. Following a launch meeting in April 2015 the trial opened in July (all centers opened October 2015). To help train research staff with introducing the trial to patients, mock patient consultations were recorded. Recruitment was initially slow. Specific research nurse meetings have taken place (December 2015 and June 2016) to understand the barriers to recruitment, center-specific issues and provide additional education to improve nurses’ confidence in recruiting patients. Regular updates are provided with monthly emails and In February 2016, the Chief Investigator and Trial Manager visited each site to promote the trial and help with any local barriers to recruitment. In response to feedback, changes to the protocol to aid patient recruitment, additional promotional and patient information provided and a video for patients were produced. The study has also been presented at various Oncology/thoracic meetings. As a result recruitment has increased with 15 patients successfully randomized into the trial. Whether SABR is an alternative to surgery is a key question in stage I NSCLC. However, SABRtooth is a challenging study but with a novel trial design and continual adaptive feedback we hope to be able to meet recruitment targets and demonstrate that a definitive phase III RCT is feasible.