Trial Information
Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)
Inclusion Criteria:
- Able to give informed written consent in the English language
- Able and willing to attend St Georges Hospital / Royal Marsden Hospital for stent
insertion (if allocated) and documentation of 6 minute walking distance.
- Willing to re-attend for follow-up and 6 minute walking distance at St Georges
Hospital / Royal Marsden Hospital 2 weeks later (all patients)
- Diagnosis of non-small cell lung cancer with centrally placed tumour with some degree
of airway obstruction from information from bronchoscopy or CT scan.
- ECOG Performance status: 0-3
Exclusion Criteria:
- Relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation
problems.
- Pregnancy
- Radically treatable disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Outcome Measure:
The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment.
Safety Issue:
No
Principal Investigator
Mary O'Brien
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United Kingdom: Research Ethics Committee
Study ID:
CCR2987
NCT ID:
NCT01003522
Start Date:
September 2008
Completion Date:
March 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- Bronchial stents
- Airway obstruction
- Non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms