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Table 2 SABRTooth trial inclusion and exclusion criteria

From: 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

Inclusion criteria

1. Histological and/or clinical and radiological diagnosis of NSCLC

2. Primary tumour characteristics

i. Peripherally located tumour as defined in the RTOG 0236 and UK SABR consortium guidelines. This states that the tumour must be more than 2 cm in axial diameter from a major airway = “No Fly Zone”. This includes the trachea, carina, right and left main bronchus and extends to the bifurcation of the right upper, right middle, right lower, left upper and left lower lobe bronchioles. Maximal axial diameter ≤5 cm measured on lung windows on computed tomography (CT).

3. No evidence of hilar or mediastinal lymph node involvement. Any hilar or mediastinal lymph nodes that are either PET positive or >1 cm in short diameter must be sampled by endo-bronchial ultrasound or oesophageal endoscopic ultrasound or mediastinoscopy and demonstrate negative cytology and/or pathology.

4. The local lung cancer MDT is of the opinion that a patient is considered suitable for either surgical resection or SABR treatment AND also to be at higher risk complications from surgical resection.

5. Age ≥18

6. Female patients must satisfy the investigator that they are not of childbearing potential or not pregnant (i.e. be willing to undergo a pregnancy test within 72 hours of surgery or day 1 of SABR) or are not of childbearing potential.

7. Able and willing to provide written informed consent

Exclusion criteria

1. Previous radiotherapy within the planned treatment volume

2. History of clinically significant diffuse interstitial lung disease

3. Any history of concurrent or previous invasive malignancy that in the opinion of the investigator could impact on trial outcomes

4. Clinical or radiological evidence of metastatic spread

5. History of psychiatric or addictive disorder, or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirement.

6. Previous systemic therapies, including targeted and experimental treatments, for their current lung cancer diagnosis