Randomised evaluation of stents to open restricted airways in patients with centrally placed non-small cell lung cancer
ISRCTN | ISRCTN66557660 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN66557660 |
ClinicalTrials.gov number | NCT01003522 |
Secondary identifying numbers | 6064 |
- Submission date
- 21/10/2010
- Registration date
- 21/10/2010
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Ms Alison Norton
Scientific
Scientific
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Phone | +44 20 8661 3276 |
---|---|
Alison.Norton@icr.ac.uk |
Study information
Study design | Multicentre randomised interventional phase III treatment trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Study acronym | RESTORE-AIR |
Study objectives | 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(s) | MREC for Wales, 03/04/2008, ref: 08/MRE09/6 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Improvement in dyspnoea, measured at 2 weeks |
Secondary outcome measures | No secondary outcome measures. |
Overall study start date | 13/10/2008 |
Completion date | 01/03/2010 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 60; UK sample size: 60 |
Total final enrolment | 21 |
Key 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 |
Key exclusion criteria | 1. Relative contraindications to stenting, e.g. bleeding abnormality or relative anticoagulation problems 2. Pregnancy 3. Surgically resectable disease |
Date of first enrolment | 13/10/2008 |
Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Sutton
SM2 5PT
United Kingdom
Sponsor information
The Royal Marsden Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Fulham Road
London
SW3 6JJ
England
United Kingdom
Website | http://www.royalmarsden.nhs.uk |
---|---|
https://ror.org/0008wzh48 |
Funders
Funder type
Research organisation
Marie Curie Fellowship (UK)
No information available
National Cancer Research Institute
Government organisation / Research institutes and centers
Government organisation / Research institutes and centers
- Alternative name(s)
- NCRI
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
28/02/2019: No publications found in PubMed, verifying study status with principal investigator.
14/03/2017: No publications found in PubMed, verifying study status with principal investigator.