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

Non-small Cell Lung Cancer Clinical Trial

— RESTORE-AIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01003522
• Other study ID #: CCR2987
• Status: Recruiting
• Phase: Phase 3
• First received: October 27, 2009
• Last updated: October 27, 2009
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: October 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Mary O'Brien
• Phone: 02086613278
• Email: mary.o'brien[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.
• 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.
• 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
• Spirometry & flow volume loop assessment
All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	To compare arterial blood gases (oxygenation of blood) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.			No
Secondary	To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.			No
Secondary	To compare other symptoms such as anxiety and breathlessness, as measured by standard scales (e.g. VAS, Borg scales) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group			No
Secondary	To measure quality of life with standard questionnaires			No
Secondary	To compare survival rates at 6 months and 1 year between the stented group and standard treatment group			No
Secondary	To document any subsequent treatments given to patients in each group			No
Secondary	To establish the feasibility of collecting fresh and formalin fixed, paraffin embedded tumour and normal bronchial tissue, and germ-line DNA for future research into NSCLC carcinogenesis and corollary translational work			No
Secondary	Formal objective response assessment is not required at 3 months, but where this is possible, this will be described			No