A Study to Determine the Feasibility and Acceptability of Conducting a Phase III Randomised Controlled Trial Comparing Stereotactic Ablative Radiotherapy With Surgery in paTients With Peripheral Stage I nOn-small Cell Lung Cancer cOnsidered Higher Risk of Complications From Surgical Resection

Launched by THE LEEDS TEACHING HOSPITALS NHS TRUST · Dec 11, 2015

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Primary tumour characteristics.
• • 2. 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.
• • 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
• • 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, endobronchial 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 complications from surgical resection
• • 5. Age ≥ 18
• • 6. Female patients must satisfy the investigator that they are not pregnant (negative pregnancy test within 72hrs of surgery of day 1 surgery/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 requirements
• • 6. Previous systemic therapies, including targeted and experimental treatments, for their current lung cancer diagnosis