Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer
RESTORE-AIR
Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
Started Sep 2008
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedOctober 28, 2009
October 1, 2009
1.5 years
October 27, 2009
October 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (8)
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.
To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
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
To measure quality of life with standard questionnaires
To compare survival rates at 6 months and 1 year between the stented group and standard treatment group
- +3 more secondary outcomes
Study Arms (2)
Treatment Arm A
OTHERStenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm B
OTHERStandard palliative treatment and standard dyspnoea symptom control.
Interventions
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.
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.
Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.
Patients randomised into the stenting arm will be admitted overnight for the procedure
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
All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation problems.
- Pregnancy
- Radically treatable disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary O'Brien
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
September 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 28, 2009
Record last verified: 2009-10