- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03870152
Electrocautery Ablation for the Prevention of Lung Cancer (EARL)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- UCLH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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.
Exclusion criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EC treatment (Intervention Arm)
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).
|
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.
|
No Intervention: AFB Surveillance (Control Arm)
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years post randomisation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: EARL Trial Coordinator, UCL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCL/12/1585
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer Squamous Cell
-
National Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Unresectable Lung Non-Small Cell Carcinoma | Unresectable Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic...United States
-
UNC Lineberger Comprehensive Cancer CenterNot yet recruitingSquamous Cell Carcinoma of Head and Neck | Squamous Non-small Cell Lung Cancer | Squamous Cell Lung CancerUnited States
-
University Hospital RegensburgThe Anticancer FundUnknownNon-Small Cell Lung Cancer | Squamous Cell Lung Cancer | Non-Squamous Cell Lung CancerGermany
-
National Cancer Institute (NCI)Not yet recruitingHead and Neck Cancer | Lung Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Non-small Cell Lung Cancer | Sinonasal Cancer | Head and Neck CarcnimonaUnited States
-
Seagen Inc.Merck Sharp & Dohme LLCTerminatedMelanoma | Small Cell Lung Cancer | Prostate Cancer | Gastric Adenocarcinoma | Head and Neck Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | Gastroesophageal Junction Adenocarcinoma | Non-small Cell Lung Cancer, Squamous | Non-small Cell Lung Cancer, Non-squamousUnited States, Korea, Republic of, Italy, United Kingdom, Australia, Taiwan
-
Roswell Park Cancer InstituteRecruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Recurrent Head and Neck Squamous... and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnHead and Neck Squamous Cell Carcinoma | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1... and other conditionsUnited States
-
National Cancer Institute (NCI)RecruitingLung Non-Small Cell Carcinoma | Lung Non-Small Cell Squamous Carcinoma | Lung Non-Squamous Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8United States, Guam
-
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Shandong Cancer Hospital and InstituteRecruitingBreast Cancer | Small Cell Lung Cancer | Colorectal Cancer | Advanced Solid Tumor | Non-small Cell Lung Cancer | Squamous Cell Cancer of Head and NeckChina
-
Hunan Province Tumor HospitalRecruitingNon-Small Cell Lung CancerChina
Clinical Trials on Electrocautery Ablation (EC)
-
Sun Yat-sen UniversityRecruitingSurgery | Recurrent Nasopharyngeal CarcinomaChina
-
Aga Khan UniversityCompleted
-
Royal Infirmary of EdinburghUnknownOsteo Arthritis Knee | Arthroplasty, Replacement, KneeUnited Kingdom
-
Unity Health TorontoUnknownSurgery | Pituitary Tumor | Olfactory Nerve InjuriesCanada
-
Dartmouth-Hitchcock Medical CenterEthicon Endo-SurgeryTerminated
-
Dr. Sam M. WisemanRecruiting
-
Turku University HospitalTerminated
-
St. Paul's Hospital, CanadaCompletedSurgical Wound Infection | Post-operative Pain | Wound ComplicationCanada
-
University of British ColumbiaNot yet recruitingPostoperative Complications | Surgical Wound Infection | Scar | Post-operative Pain | Wound ComplicationCanada
-
Wielkopolskie Centrum Pulmonologii i TorakochirurgiiMedtronicCompletedLung Cancer | Complication of Surgical ProcedurePoland