Condition category
Cancer
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Alison Norton

ORCID ID

Contact details

Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
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 on 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
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

http://www.royalmarsden.nhs.uk

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

Publication citations

Additional files

Editorial Notes