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

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

Study designMulticentre randomised interventional phase III treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRandomised 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 acronymRESTORE-AIR
Study objectivesThis 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) studiedTopic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (non-small cell)
InterventionBronchial stent insertion versus no stent.

Follow up length: 3 months
Study entry: single randomisation only
Intervention typeOther
Primary outcome measureImprovement in dyspnoea, measured at 2 weeks
Secondary outcome measuresNo secondary outcome measures.
Overall study start date13/10/2008
Completion date01/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 60; UK sample size: 60
Total final enrolment21
Key inclusion criteria1. 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 criteria1. Relative contraindications to stenting, e.g. bleeding abnormality or relative anticoagulation problems
2. Pregnancy
3. Surgically resectable disease
Date of first enrolment13/10/2008
Date of final enrolment01/03/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor information

The Royal Marsden Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Fulham Road
London
SW3 6JJ
England
United Kingdom

Website http://www.royalmarsden.nhs.uk
ROR logo "ROR" 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
Alternative name(s)
NCRI
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.