Electrocautery Ablation for the Prevention of Lung Cancer

NCT03870152 | Terminated Phase 2 DMC

• 1 other identifier: UCL/12/1585
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer Squamous Cell

Outcome Measures

Primary Outcomes (1)

• The time to progression of any index HGL in a patient within a 3-year follow up (phase II and III)

  The time to progression of any index HGL in a patient to invasive lung cancer

  3 years post randomisation

Study Arms (2)

EC treatment (Intervention Arm)

EXPERIMENTAL

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).

Procedure: Electrocautery Ablation (EC)

AFB Surveillance (Control Arm)

NO INTERVENTION

Patients randomised to the surveillance (Control Arm) will have: bronchoscopy surveillance 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).

Interventions

Electrocautery Ablation (EC) PROCEDURE

For the purposes of the trial, one round of EC treatment consists of two individual EC treatments with a post-EC bronchoscopy in between to check for a response to the 1st EC treatment. Within each round, the second EC treatment will only be administered if the post-treatment bronchoscopy confirms presence of persistent high grade disease. 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.

EC treatment (Intervention Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 pregnancy test at the following time points:
• One pregnancy test prior to registration
• 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.
• Finding of (micro)-invasive disease on histology (assessed at randomisation)
• 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

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator

Study Sites (1)

UCLH

London, United Kingdom

Location

Study Officials

• EARL Trial Coordinator

  UCL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: October 29, 2020
• Primary Completion: September 2, 2022
• Study Completion: October 11, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

GB (1)