LungTech Stereotactic Body Radiotherapy Trial
Research type
Research Study
Full title
LungTech Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located Non-Small Cell Lung Cancer (NSCLC): A Phase II Study.
IRAS ID
163097
Contact name
Corinne Faivre-Finn
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
5 years, 6 months, 1 days
Research summary
Non-small cell lung cancer (NSCLC) accounts for 80-85% of lung cancers with 20% of patients (~7000 in the UK) presenting with early stage disease. Gold standard treatment for early stage central NSCLC is surgery to remove a section of the lung (5 year survival 50-70%). For the 50% of NSCLC patients unsuitable for or declining surgery standard radiotherapy is generally offered, but local control of disease and survival rates are poor.
Stereotactic body radiotherapy (SBRT) is considered a superior treatment option as local control rates of around 90% have been reported. However, available safety data mostly relates to tumours measuring 5cm in diameter, located in the periphery of the lung. SBRT is not currently considered a standard treatment option in early stage central NSCLC due to lack of evidence supporting its effectiveness and safety.
The aim of this non randomised, single arm, international, multi-centre, phase II study is to assess the efficacy and toxicity of SBRT in inoperable, centrally located early stage NSCLC in a multi-centre setting. Primary endpoint is freedom from local progression at 3 years. Secondary endpoints are overall survival, cause of death, pattern of recurrence (local/distant), acute and late toxicity.
150 patients will be recruited from 23 European centres in 7 countries (including 35 patients at 5 UK centres) over 2 years.
Data on safety and effectiveness of SBRT for central NSCLC tumours is limited, the ability to apply the results hampered by different techniques and treatment schedules used at different centres. Additionally SBRT has not been evaluated alongside other standard treatments with long term follow-up. Lack of evidence supporting SBRT is reflected in that international guidelines only recommend SBRT for peripheral and inoperable early stage NSCLC. Results from the proposed study are likely to be practice changing, establishing this treatment as a new standard of care.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0076
Date of REC Opinion
25 Feb 2015
REC opinion
Favourable Opinion