Feasibility Study to Estimate Number of Patients With Precancerous Areas in Their Airways and the Response to Gefitinib (TIDAL1)
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tyrosine Kinase Inhibitors in DyplAsia of Lung Epithelium|
- Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia [ Time Frame: during the screening broncoscopy - carried out within the first month post consent ] [ Designated as safety issue: No ]Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.
- Acceptability of screening patients as measured by success of trial recruitment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Response of high grade dysplasia to treatment (complete / partial / stable / progression) [ Time Frame: 6 & 12 months ] [ Designated as safety issue: No ]
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.
- Toxicity and acceptability of treatment (proportion of patients refusing study entry). [ Time Frame: 2 weeks, 4 weeks, 3 & 6 months ] [ Designated as safety issue: Yes ]
- Successful biobanking of samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Single arm study
250mg od for 6 months
Other Name: IRESSA
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405846
|Contact: Vikki Hughes, PhD||01480 firstname.lastname@example.org|
|Contact: Amanda Stone||01480 email@example.com|
|Papworth Hospital NHS Trust||Recruiting|
|Papworth Everard, Cambs, United Kingdom, CB23 3RE|
|Principal Investigator: Robert Rintoul, Dr|
|Study Chair:||Tim Eisen, Professor||Papworth Hospital NHS Trust|
|Principal Investigator:||Robert Rintoul, Dr||Papworth Hospital NHS Trust|