Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Alison Norton
ORCID ID
Contact details
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 20 8661 3276
Alison.Norton@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01003522
Protocol/serial number
6064
Study information
Scientific title
Randomised Evaluation of STents to Open REstricted AIRways in patients with centrally placed non-small cell lung cancer: a multicentre randomised interventional phase III treatment trial
Acronym
RESTORE-AIR
Study hypothesis
This study intends to build on a previous small pilot study which showed good improvement in breathlessness in lung cancer patients with the insertion of a bronchial stent. We wish to compare the improvement in dyspnoea with or without a bronchial stent at 2 weeks. We wish to assess if an improved clinical state improves outcomes of tumour specific therapy in these patients. Subjective assessment of breathlessness will be followed, but also the use of rescue medication (such as opioids), and objective measures of pulmonary function including the 6 minute walking distance (6MWD), arterial blood gas analysis and spirometry (where possible).
Ethics approval
MREC for Wales, 03/04/2008, ref: 08/MRE09/6
Study design
Multicentre randomised interventional phase III treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (non-small cell)
Intervention
Bronchial stent insertion versus no stent.
Follow up length: 3 months
Study entry: single randomisation only
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Improvement in dyspnoea, measured at 2 weeks
Secondary outcome measures
No secondary outcome measures.
Overall trial start date
13/10/2008
Overall trial end date
01/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Able to give informed written consent in the English language
2. Male or female, aged greater than 18 years
3. Able and willing to attend St George's Hospital/Royal Marsden Hospital (RMH) for stent insertion (if allocated) and documentation of 6-minute walk distance (6MWD)
4. Willing to re-attend for follow-up and 6MWD at St George's Hospital/RMH 2 weeks later (all patients)
5. Diagnosis of non-small cell lung cancer (NSCLC) with centrally placed tumour with some degree of airway obstruction from information from bronchoscopy or computed tomography (CT) scan
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 60; UK sample size: 60
Participant exclusion criteria
1. Relative contraindications to stenting, e.g. bleeding abnormality or relative anticoagulation problems
2. Pregnancy
3. Surgically resectable disease
Recruitment start date
13/10/2008
Recruitment end date
01/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
The Royal Marsden Hospital NHS Foundation Trust (UK)
Sponsor details
Fulham Road
London
SW3 6JJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Marie Curie Fellowship (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Cancer Research Institute (NCRI) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary