NCT01003522

Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Arterial puncture	Patients will undergo arterial blood gas sampling from the radial artery. This will be done by experienced doctors who are highly skilled in this procedure.
OTHER	Venepuncture	Blood samples for baseline biochemistry, full blood count, and clotting screen will be taken. In patients additionally providing optional consent blood will be taken for laboratory based basic science research into lung cancer carcinogenesis and pharmacogenetics. Blood will be taken by qualified and experienced nurses, doctors and phlebotomists.
PROCEDURE	General anaesthetic	Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.
PROCEDURE	Inpatient stays	Patients randomised into the stenting arm will be admitted overnight for the procedure
OTHER	Walking test	All patients will be asked to complete a 6 minute walking test at baseline and on day 15. Patients randomised into the stent arm (Arm A) will complete a further 6 minute walking test at 24 hours post-stent
OTHER	Spirometry & flow volume loop assessment	All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
OTHER	Biopsy material	For patients randomised to stenting and giving additional voluntary consent, 2 pairs of biopsies of tumour tissue, and 1 pair of biopsies of normal airways tissue will be taken for basic scientific research into lung cancer carcinogenesis, and pharmacogenetics.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-10-28
• Last updated: 2009-10-28

Locations

1 site across 1 country: United Kingdom