search
Back to results

Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Arterial puncture
Venepuncture
General anaesthetic
Inpatient stays
Walking test
Spirometry & flow volume loop assessment
Biopsy material
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non-small Cell Lung Cancer focused on measuring Bronchial stents, Airway obstruction, Non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to give informed written consent in the English language
  • Able and willing to attend St Georges Hospital / Royal Marsden Hospital for stent insertion (if allocated) and documentation of 6 minute walking distance.
  • Willing to re-attend for follow-up and 6 minute walking distance at St Georges Hospital / Royal Marsden Hospital 2 weeks later (all patients)
  • Diagnosis of non-small cell lung cancer with centrally placed tumour with some degree of airway obstruction from information from bronchoscopy or CT scan.
  • ECOG Performance status: 0-3

Exclusion Criteria:

  • Relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation problems.
  • Pregnancy
  • Radically treatable disease.

Sites / Locations

  • Royal Marsden NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Treatment Arm A

Treatment Arm B

Arm Description

Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control

Standard palliative treatment and standard dyspnoea symptom control.

Outcomes

Primary Outcome Measures

The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment.

Secondary Outcome Measures

To compare arterial blood gases (oxygenation of blood) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
To compare other symptoms such as anxiety and breathlessness, as measured by standard scales (e.g. VAS, Borg scales) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group
To measure quality of life with standard questionnaires
To compare survival rates at 6 months and 1 year between the stented group and standard treatment group
To document any subsequent treatments given to patients in each group
To establish the feasibility of collecting fresh and formalin fixed, paraffin embedded tumour and normal bronchial tissue, and germ-line DNA for future research into NSCLC carcinogenesis and corollary translational work
Formal objective response assessment is not required at 3 months, but where this is possible, this will be described

Full Information

First Posted
October 27, 2009
Last Updated
October 27, 2009
Sponsor
Royal Marsden NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01003522
Brief Title
Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer
Acronym
RESTORE-AIR
Official Title
Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Bronchial stents, Airway obstruction, Non-small cell lung cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A
Arm Type
Other
Arm Description
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Arm Title
Treatment Arm B
Arm Type
Other
Arm Description
Standard palliative treatment and standard dyspnoea symptom control.
Intervention Type
Other
Intervention Name(s)
Arterial puncture
Intervention Description
Patients will undergo arterial blood gas sampling from the radial artery. This will be done by experienced doctors who are highly skilled in this procedure.
Intervention Type
Other
Intervention Name(s)
Venepuncture
Intervention Description
Blood samples for baseline biochemistry, full blood count, and clotting screen will be taken. In patients additionally providing optional consent blood will be taken for laboratory based basic science research into lung cancer carcinogenesis and pharmacogenetics. Blood will be taken by qualified and experienced nurses, doctors and phlebotomists.
Intervention Type
Procedure
Intervention Name(s)
General anaesthetic
Intervention Description
Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.
Intervention Type
Procedure
Intervention Name(s)
Inpatient stays
Intervention Description
Patients randomised into the stenting arm will be admitted overnight for the procedure
Intervention Type
Other
Intervention Name(s)
Walking test
Intervention Description
All patients will be asked to complete a 6 minute walking test at baseline and on day 15. Patients randomised into the stent arm (Arm A) will complete a further 6 minute walking test at 24 hours post-stent
Intervention Type
Other
Intervention Name(s)
Spirometry & flow volume loop assessment
Intervention Description
All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
Intervention Type
Other
Intervention Name(s)
Biopsy material
Intervention Description
For patients randomised to stenting and giving additional voluntary consent, 2 pairs of biopsies of tumour tissue, and 1 pair of biopsies of normal airways tissue will be taken for basic scientific research into lung cancer carcinogenesis, and pharmacogenetics.
Primary Outcome Measure Information:
Title
The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment.
Secondary Outcome Measure Information:
Title
To compare arterial blood gases (oxygenation of blood) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
Title
To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
Title
To compare other symptoms such as anxiety and breathlessness, as measured by standard scales (e.g. VAS, Borg scales) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group
Title
To measure quality of life with standard questionnaires
Title
To compare survival rates at 6 months and 1 year between the stented group and standard treatment group
Title
To document any subsequent treatments given to patients in each group
Title
To establish the feasibility of collecting fresh and formalin fixed, paraffin embedded tumour and normal bronchial tissue, and germ-line DNA for future research into NSCLC carcinogenesis and corollary translational work
Title
Formal objective response assessment is not required at 3 months, but where this is possible, this will be described

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to give informed written consent in the English language Able and willing to attend St Georges Hospital / Royal Marsden Hospital for stent insertion (if allocated) and documentation of 6 minute walking distance. Willing to re-attend for follow-up and 6 minute walking distance at St Georges Hospital / Royal Marsden Hospital 2 weeks later (all patients) Diagnosis of non-small cell lung cancer with centrally placed tumour with some degree of airway obstruction from information from bronchoscopy or CT scan. ECOG Performance status: 0-3 Exclusion Criteria: Relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation problems. Pregnancy Radically treatable disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Mary O'Brien
Phone
02086613278
Email
mary.o'brien@rmh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary O'Brien
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

We'll reach out to this number within 24 hrs