We are going to use a special type of bronchoscopy test to examine patients who have had previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine a) whether we can identify precancerous changes in their airways b) whether this type of testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has any effect on precancerous areas in the airway.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
250mg od for 6 months
Papworth Hospital NHS Trust
Papworth Everard, Cambs, United Kingdom
Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia
Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.
Time frame: during the screening broncoscopy - carried out within the first month post consent
Acceptability of screening patients as measured by success of trial recruitment
Time frame: 12 months
Response of high grade dysplasia to treatment (complete / partial / stable / progression)
To be estimated by photography \& biopsy of the lesions \& comparison with previous findings: Complete response: Complete resolution of a dysplastic lesion Partial response: Reduction of a dysplastic lesion by \>=50% OR Reduction in grade of a high grade dysplastic lesion Progressive disease: Development of a new area of high grade dysplasia or invasive malignancy in an area of previous low grade dysplasia or normal epithelium OR Development of a higher grade lesion in an area of previous high grade dysplasia OR Increase in surface area of \>=50%. Stable disease: None of the above.
Time frame: 6 & 12 months
Toxicity and acceptability of treatment (proportion of patients refusing study entry).
Time frame: 2 weeks, 4 weeks, 3 & 6 months
Successful biobanking of samples
Time frame: 12 months
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