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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01003522
First received: October 27, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Other: Arterial puncture
Other: Venepuncture
Procedure: General anaesthetic
Procedure: Inpatient stays
Other: Walking test
Other: Spirometry & flow volume loop assessment
Other: Biopsy material
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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. [ Designated as safety issue: No ]

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. [ Designated as safety issue: No ]
  • To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group. [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • To measure quality of life with standard questionnaires [ Designated as safety issue: No ]
  • To compare survival rates at 6 months and 1 year between the stented group and standard treatment group [ Designated as safety issue: No ]
  • To document any subsequent treatments given to patients in each group [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Formal objective response assessment is not required at 3 months, but where this is possible, this will be described [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003522

Contacts
Contact: Dr Mary O'Brien 02086613278 mary.o'brien@rmh.nhs.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Mary O'Brien Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Mary O'Brien, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01003522     History of Changes
Other Study ID Numbers: CCR2987
Study First Received: October 27, 2009
Last Updated: October 27, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Bronchial stents
Airway obstruction
Non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014