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

October 27, 2009 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Other: Arterial puncture
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.
Other: Venepuncture
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.
Procedure: General anaesthetic
Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.
Procedure: Inpatient stays
Patients randomised into the stenting arm will be admitted overnight for the procedure
Other: Walking test
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
Other: Spirometry & flow volume loop assessment
All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
Other: Biopsy material
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.
Other: Treatment Arm B
Standard palliative treatment and standard dyspnoea symptom control.
Other: Arterial puncture
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.
Other: Venepuncture
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.
Other: Walking test
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
Other: Spirometry & flow volume loop assessment
All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Mary O'Brien, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2009

Last Update Submitted That Met QC Criteria

October 27, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR2987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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