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 Higher risk of complications from surgical resection.

eeds Teaching Hospitals NHS Trust0 sites24 target enrollmentFebruary 4, 2015

Overview

Registry

who.int

Start Date

February 4, 2015

End Date

January 31, 2017

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

eeds Teaching Hospitals NHS Trust

•Main study:
•1\. Histological and/or clinical and radiological diagnosis of NSCLC
•2\. Primary tumour characteristics:
•2\.1\. Peripherally located tumour as defined in the RTOG 0236 study and UK SABR Consortium guidelines. This states that the tumour must be more than 2cm 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 (See diagram below).
•2\.2\. Maximal axial diameter \= 5 cm measured on lung windows on computed tomography.
•3\. No evidence of hilar or mediastinal lymph nodes involvement. Any hilar or mediastinal lymph nodes that are either PET positive or \>1cm in axial dimension must be sampled by mediastinoscopy, endo\-bronchial ultrasound or oesophageal endoscopic ultrasound and demonstrate negative cytology and/or pathology.
•4\. Local lung cancer MDT consensus opinion that patient is considered suitable for either surgical resection or SABR treatment and also to be at higher risk of complications from surgical resection.
•5\. Age \= 18
•6\. Female patients must satisfy the investigator that they are either not of childbearing potential or not pregnant (i.e. be willing to undergo a pregnancy test within 72hrs of surgery or day 1 of SABR treatment),.
•7\. Able and willing to provide written informed consent.

•Main study:
•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 requirements
•6\. Previous systemic therapies, including targeted and experimental treatments, for their current lung cancer diagnosis.
•Qualitative sub¬study:
•1\. Decline participation in this study
•2\. Unable to comply with requirements of this study protocol