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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
29/10/2020
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Sam Janes
Recruitment target:
101 (for randomisation)
EudraCT number:
N/A
Contact details:
ctc.earl@ucl.ac.uk
Lay summary:
EARL
Electrocautery Ablation for the Prevention of Lung Cancer
Description
Design: 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 autofluorescence bronchoscopy (AFB) 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 AFB surveillance (= intervention), or AFB surveillance (= control). 
Treatment: Electrocautery treatment uses an electrical current to destroy cells. Electrocautery treatment (EC) is performed during AFB. A tube is inserted into the airway (bronchoscope) and once in position, an electrical current is passed through a probe placed near the lesion. The tip of the probe is heated by the electric current to burn or destroy the lesion. Participants in the intervention arm will receive up to nine individual EC treatments in total during the study. Follow up in both arms consists of AFB surveillance at 6, 12, 24, 36 months post-randomisation (and/or 18 and 30 months depending on lesion appearance) with CT scanning of the thorax and spirometry at 12, 24 and 36 months post randomisation. Translational samples for research will also be collected during the study.
Key inclusion/exclusion criteria: Histopathological confirmation of ≥1 lung HGL. Patients with HGLs which have remained stable on AFB surveillance for ≥5 years are excluded. Previous radiotherapy to the central airways is also is also not permitted.
Duration of recruitment: We need to randomise approximately 106 patients into the study (phase II and III) over 3 years. Anticipated recruitment for phase II is 1 year (12 months), and an additional 2 years (24 months) for the phase III.
Aim

The main objective of the phase II component is to demonstrate that a sufficient number of patients with high-grade lesions (HGLs) respond to EC treatment: the proportion of patients who respond to treatment will be examined for the EC arm only. This will be used as evidence of an efficacy signal of EC treatment to determine whether the study will continue into phase III. 

The primary objective of the phase III trial is to show that airway high grade lesions (HGLs) treated with electrocautery (EC) ablation are less likely to progress to invasive lung cancer compared to surveillance alone.


Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
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Telephone:
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020 7679 9899
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