Lung Cancer Squamous CellPhase 2/3EARLNCT03870152
Electrocautery Ablation for the Prevention of Lung Cancer
A Phase 2/3 study testing Electrocautery Ablation (EC) in people with Lung Cancer Squamous Cell, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Squamous Cell
- What is being tested?
- Electrocautery Ablation (EC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Oct 2020to 11 Oct 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 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.
Who cannot join
- 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
- Previous radiotherapy to the treatment area
- ECOG Performance Score >2
- Patients who have one or more HGL greater than 3cm in length
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Cancer Squamous Cell
- Being tested
- Electrocautery Ablation (EC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocautery Ablation (EC)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start29 Oct 2020
- Primary completion2 Sep 2022
- Study completion11 Oct 2022
Why it stopped: This decision was made due to lower than expected recruitment levels into the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Squamous CellStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- EARL Trial Coordinator, Study chair, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870152
- Sponsor's protocol ID
- UCL/12/1585
- Acronym
- EARL
- Status last verified
- Oct 2022
- First submitted
- 8 Mar 2019
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocautery Ablation for the Prevention of Lung Cancer
- ClinicalTrials.gov ID
- NCT03870152
- Acronym / sponsor ID
- EARL / UCL/12/1585
- Conditions
- Lung Cancer Squamous Cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision was made due to lower than expected recruitment levels into the trial
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC treatment (Intervention Arm) | Experimental | Procedure: 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with ≥1 airway HGL (defined as severe dysplasia or carcinoma in situ on histology)
- PRE-REGISTRATION
- 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
Key exclusion criteria (14 listed)
- 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
- Previous radiotherapy to the treatment area
- ECOG Performance Score >2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocautery Ablation (EC)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. | Procedure or surgery | EC treatment (Intervention Arm) |
Primary outcome
The time to progression of any index HGL in a patient within a 3-year follow up (phase II and III)
Time frame: 3 years post randomisation
The time to progression of any index HGL in a patient to invasive lung cancer
Results and safety
The study was stopped early (reason given: This decision was made due to lower than expected recruitment levels into the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EARL Trial Coordinator study chair
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Electrocautery Ablation (EC) in people with Lung Cancer Squamous Cell, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This decision was made due to lower than expected recruitment levels into the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to progression of any index HGL in a patient within a 3-year follow up (phase II and III) (time frame: 3 years post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.