TIDAL 1 Version 1.0

• Research type

  Research Study

• Full title

  Tyrosine kinase Inhibitors in DysplAsia of Lung epithelium Study 1

• IRAS ID

  59845

• Contact name

  Tim Eisen

• Sponsor organisation

  Papworth Hospital NHS Foundation Trust

• Eudract number

  2010-023355-29

• ISRCTN Number

  n/a

• Research summary

  During the development of squamous cell lung cancer, the cells which line the airways (windpipe) go through a series of changes. These changes occur in a step-wise fashion whereby tissue becomes increasingly abnormal before potentially transforming into invasive cancer. This study has been designed to see if it is possible to reduce the risk of lung cancer developing in people who are known to be at risk of the disease. In order to do this, it is important to know how many people who are at known to be at risk have pre-cancerous change in the lungs. We also need to know whether this problem can be reversed or resolved by taking a drug called Gefitinib. We aim to enrol 40 patients who have completed curative treatment for non-small cell lung cancer or squamous cell head and neck cancer, a group that are known to be at high risk of developing cancer in the airways. Patients who consent to the screening phase of the study will have a CT scan and auflurescence bronchoscopy. If suspicious areas are identified, biopsies (small samples of tissue) will be taken. If pre-cancerous change is found, patients will be offered Gefitinib 250mg once a day for 6 months. Patients will be monitored closely during their treatment for side-effects of the study drug. At the end of treatment and then again 6 months later, they will have another bronchoscopy to assess the response of the abnormal areas to treatment. TIDAL 1 is a single centre, feasibility study which is the first in a series of planned studies. It is anticipated that recruitment will take 2 years with a further 1 year allocated for patient follow-up.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  11/H0304/8

• Date of REC Opinion

  15 Mar 2011

• REC opinion

  Further Information Favourable Opinion