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dc.contributor.authorKalinke, L.
dc.contributor.authorThakrar, R.
dc.contributor.authorDaniels, H.
dc.contributor.authorRintoul, R.
dc.contributor.authorBooton, R.
dc.contributor.authorHackshaw, Allan
dc.contributor.authorJanes, S.
dc.date.accessioned2021-01-06T11:15:21Z
dc.date.available2021-01-06T11:15:21Z
dc.date.issued2020en
dc.identifier.citationKalinke L, Thakrar R, Daniels H, Rintoul R, Booton R, Hackshaw A, et al. EARL: a multicentre phase III randomised trial to evaluate the efficacy of endobronchial electrocautery with autofluorescence bronchoscopy (AFB) surveillance versus AFB surveillance alone in high-grade bronchial dysplasia. Lung Cancer. 2020;139:S92-S3en
dc.identifier.urihttp://hdl.handle.net/10541/623612
dc.description.abstractIntroduction: Bronchial pre-invasive lesions are precursors of squamous cell cancer. However, not every pre-invasive lesion is destined to this; some lesions may remain stable or even regress to normal epithelium. Performing surveillance with autofluorescence bronchoscopy (AFB), we have shown that 50% of high-grade lesions (HGLs), i.e. severe dysplasia/carcinoma in-situ, progress to cancer (unpublished). Their treatment remains controversial. Guidelines advocate surgical management. This carries inherent risk and its benefit has not been proven in a randomised trial; new lesions also develop, so a tissue-sparing strategy is needed. Methods: We are conducting a Cancer Research UK-funded, international multi-centre randomised trial to examine whether thermal ablation using bronchoscopic electrocautery of HGLs prevents their progression to cancer. Participants will be randomised to electrocautery and AFB surveillance or AFB surveillance alone. The trial will run across four centres (University College London Hospital, Wythenshawe, Papworth and VUmc, Amsterdam)and opens in December 2019. We aim to recruit 106 participants within 3 years. Referral criteria are: 1. Individuals with HGLs found incidentally on bronchial biopsy or at resection margins post-operatively (even if found up to one year previously) 2. Individuals with abnormal sputum cytology, but normal CT and/or bronchoscopy All participants will have a chest CT, pulmonary function tests and AFB at baseline, and then AFB at 6, 12, 24 and 36 months. Participants can receive two electrocautery treatments per year over the 3-year trial period. Results: The primary endpoint is the time to progression of any HGL in a patient to invasive lung cancer. Secondary outcomes are (i) cancer-free and overall survival, (ii) health-related quality of life and (iii) cost-effectiveness. Conclusion: The EARL trial is the first Phase III randomised trial of an endobronchial therapy for the prevention of lung cancer. If successful, it will address the unmet clinical need for a proven tissue-sparing therapy for this high-risk population.en
dc.language.isoenen
dc.titleEARL: a multicentre phase III randomised trial to evaluate the efficacy of endobronchial electrocautery with autofluorescence bronchoscopy (AFB) surveillance versus AFB surveillance alone in high-grade bronchial dysplasiaen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentLungs for Living Research Unit, London, United Kingdomen
dc.identifier.journalLung Canceren
dc.description.noteen]


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