Electrocautery Ablation for the Prevention of Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer Squamous Cell
• Interventions: Procedure: Electrocautery Ablation (EC)

• Registration Number: NCT03870152
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2020-10-29
• Primary Completion: 2022-09-02
• Status Verified: 2022-10
• Study Completion: 2022-10-11
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EC treatment (Intervention Arm)	Electrocautery Ablation (EC)	Patients in the intervention arm will receive up to three rounds of EC treatment (no more than one round annually) to all their HGLs identified at baseline. Follow-up is the same as for Control Arm patients: a bronchoscopy surveillance visit at 6, 12, 24, and at 36 months post-randomisation; with further bronchoscopy surveillance visits at 18 and/or at 30 months post-randomisation (dependent on lesion appearance).

Primary Outcome Measures

Name	Time	Method
The time to progression of any index HGL in a patient within a 3-year follow up (phase II and III)	3 years post randomisation	The time to progression of any index HGL in a patient to invasive lung cancer

Trial Locations

Locations (1)

UCLH; 🇬🇧 London, United Kingdom