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 (NCT)	NCT01003522
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	6064
Sponsor	The Royal Marsden Hospital NHS Foundation Trust (UK)
Funders	Marie Curie Fellowship (UK), National Cancer Research Institute

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-stents-to-relieve-breathlessness-for-non-small-cell-lung-cancer-restore-air

Contact information

Ms Alison Norton
Scientific

Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 20 8661 3276
Email	Alison.Norton@icr.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional phase III treatment trial
Secondary study design	Randomised controlled trial
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(s)	Improvement in dyspnoea, measured at 2 weeks
Key secondary outcome measure(s)	No secondary outcome measures.
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Royal Marsden Hospital

Downs Road
Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.