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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

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.

Safety Issue:

No

Principal Investigator

Mary O'Brien

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CCR2987

NCT ID:

NCT01003522

Start Date:

September 2008

Completion Date:

March 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Bronchial stents
  • Airway obstruction
  • Non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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