Spots Global Cancer Trial Database for Electrocautery Ablation for the Prevention of Lung Cancer

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Trial Identification

Brief Title: Electrocautery Ablation for the Prevention of Lung Cancer

Official Title: Electrocautery Ablation for the Prevention of Lung Cancer

Study ID: NCT03870152

Conditions

Lung Cancer Squamous Cell

Interventions

Electrocautery Ablation (EC)

Study Description

Brief Summary: This study evaluates whether EC treatment is effective in delaying the progression of high-grade lung lesion(s) to invasive lung cancer. Participants will be randomised to receive either electrocautery (EC) treatment with bronchoscopy surveillance (=intervention), or bronchoscopy surveillance alone (=control) in a 2:1 ratio.

Detailed Description: Squamous cell carcinoma of the lung develops through a transition of progressive cytological aberration, from normal to metaplasia, mild, moderate, and severe dysplasia and then carcinoma in situ (CIS) before becoming an invasive cancer. Progression rates to invasive carcinoma can vary depending on the initial grade of the lesion and it is generally accepted that high-grade lesions are more likely to progress to invasive cancer than low-grade lesions. Early detection and treatment of these lesions is critical to improving survival. There is no evidence base examining how, or whether these high-grade lesions (HGLs) should be treated, resulting in diverse treatment practices both nationally and internationally. This is the first randomised clinical trial of a bronchoscopic intervention in treating HGLs using EC. EARL is a phase II/III multicentre 2:1 randomised controlled trial to evaluate the effectiveness of electrocautery (EC) in the treatment of high-grade lesions of the lung. All patients consented/registered onto the trial will have an bronchoscopy (AFB or NBI) to check for high-grade lesions (HGLs) in the lung, as verified by tissue biopsy. Only patients with ≥1 lung histologically confirmed lung HGL will be randomised to receive either electrocautery ablation (EC) treatment and bronchoscopy surveillance (= intervention), or bronchoscopy surveillance (= control). The principal objective of the main phase II trial is to demonstrate that airway High-Grade Lesions (HGLs) that are treated with electrocautery are less likely to progress to lung cancer compared to HGLs that are not treated with electrocautery.