Status:
TERMINATED
Electrocautery Ablation for the Prevention of Lung Cancer
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Conditions:
Lung Cancer Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 electrocauter...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03870152
Start Date
October 29 2020
End Date
October 11 2022
Last Update
October 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLH
London, United Kingdom