Electrocautery Ablation for the Prevention of Lung Cancer (EARL)

  • STATUS
    Recruiting
  • End date
    Jun 4, 2026
  • participants needed
    111
  • sponsor
    University College, London
Updated on 4 May 2022

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.

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.

Details
Condition Lung Cancer Squamous Cell
Treatment Electrocautery Ablation (EC)
Clinical Study IdentifierNCT03870152
SponsorUniversity College, London
Last Modified on4 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with ≥1 airway HGL (defined as severe dysplasia or carcinoma in situ on histology)
PRE-REGISTRATION
Patient has a high likelihood of having airway HGLs as evaluated by
investigator
patient already part of existing surveillance programme or
HGL identified at other hospital and patient is referred to study site or
patient has abnormal sputa and patient is referred to study site
PRE-RANDOMISATION Following registration, patients undergo a baseline bronchoscopy and
only those with ≥1 airway HGL(s) can continue to randomisation provided they continue
to meet all the inclusion/exclusion criteria below
Absence of primary lung cancer as confirmed by CT thorax OR recent surgical removal of
a lung cancer with clear resection margins (of cancer) confirmed OR recent successful
curative SABR treatment, as confirmed by MDT
Male or female patients ≥18 years of age
No upper age limit but life expectancy thought to be at least 3 years (in the opinion
of the treating clinician)
ECOG Performance Score 0-2
FEV1 ≥ 25% of predicted
DLCO/TLCO ≥ 20% of predicted (only required for registration)
Patients who are women of child-bearing potential (WOCBP) must also have a negative
One pregnancy test prior to registration
pregnancy test at the following time points
One pregnancy test within 24 hours prior to the 1st EC treatment within each EC
treatment round
Consent to donation of biological samples for translational work. Patients will be
deemed ineligible if they do not consent to donate translational samples
Patient is willing and able to comply to protocol procedures and attend all study
visits including all bronchoscopy and EC treatment visits
if spirometry is not possible (e.g. due to COVID-19) investigator assessment that
the patient is sufficiently fit for bronchoscopy and EC treatment is permissible

Exclusion Criteria

Finding of (micro)-invasive disease on histology (assessed at randomisation)
Previous radiotherapy to the treatment area
ECOG Performance Score >2
Patients who have one or more HGL greater than 3cm in length
Patients with a history of pulmonary hypertension
Patients who are anticoagulated for prosthetic heart valves
Decompensated heart disease with life expectancy less than 3 years
Severe liver and renal insufficiency with life expectancy less than 3 years
Patients who have one or more HGL present for ≥5 years which have remained persistent
on white light or autofluorescence bronchoscopy (AFB) surveillance
Detection of active cancer or on systemic treatment for cancer, excluding basal cell
skin cancers
Patient unlikely to cooperate with a 3-year follow-up; medical or psychological
condition at the discretion of the investigator which would not permit compliance with
the protocol or meaningful signed informed consent
Participation in another study with an investigational medicinal product within one
month prior to registration
Pregnant patients (confirmed by serum/urine ß-HCG)
Any other known condition which is assessed as an intolerable risk by the investigator
upon inclusion in the study
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