A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)

Overview

In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.

Full Title of Study: “A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2011

Interventions

  • Procedure: Endobronchial or Endoscopic Ultrasound
    • Patients with anterior mediastinal or subcarinal disease will undergo EBUS. Patients with posterior, subcarinal or AP window disease will undergo EUS. Patients with no mediastinal disease on CT scan will undergo EBUS.
  • Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
    • Investigations will be determined by the multi-disciplinary team responsible for the patient

Arms, Groups and Cohorts

  • Active Comparator: B
    • Control arm: Current practice for diagnosing and staging lung cancer. Most patients with intra-thoracic disease suspected of lung cancer will undergo bronchoscopy (or CT guided biopsy), PET scan and possibly mediastinoscopy.
  • Experimental: A
    • Active arm: A new pathway for the diagnosis and staging of lung cancer with endobronchial (EBUS) or endoscopic ultrasound (EUS) as a first test. If EBUS or EUS is negative the patient will have PET scan +/- mediastinoscopy.

Clinical Trial Outcome Measures

Primary Measures

  • Time from first outpatient appointment to decision to treat
    • Time Frame: 1 – 3 months

Secondary Measures

  • The healthcare costs for diagnosing and staging lung cancer
    • Time Frame: End of study
  • The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer
    • Time Frame: 1 – 3 months
  • The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan
    • Time Frame: 1 – 3 months
  • The time from first outpatient appointment to treatment
    • Time Frame: 1 – 3 months
  • The number of futile thoracotomies
    • Time Frame: 1 – 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • Consecutive patients suspected of lung cancer on CT scan – Written informed consent – Able to tolerate bronchoscopy and thoracic surgery Exclusion Criteria:

  • Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial – Any disorder making reliable informed consent impossible – Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University College London Hospitals
  • Collaborator
    • North Middlesex University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sam Janes, Reader in Respiratory Medicine – University College London Hospitals
  • Overall Official(s)
    • Stephen Spiro, MD, Principal Investigator, Univeristy College London NHS Trust
    • Sam Janes, MD PhD, Study Chair, University College, London
    • Neal Navani, MD, Study Director, University College, London

References

Herder GJ, Verboom P, Smit EF, van Velthoven PC, van den Bergh JH, Colder CD, van Mansom I, van Mourik JC, Postmus PE, Teule GJ, Hoekstra OS. Practice, efficacy and cost of staging suspected non-small cell lung cancer: a retrospective study in two Dutch hospitals. Thorax. 2002 Jan;57(1):11-4. doi: 10.1136/thorax.57.1.11.

Detterbeck FC, Jantz MA, Wallace M, Vansteenkiste J, Silvestri GA; American College of Chest Physicians. Invasive mediastinal staging of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):202S-220S. doi: 10.1378/chest.07-1362.

Silvestri GA, Gould MK, Margolis ML, Tanoue LT, McCrory D, Toloza E, Detterbeck F; American College of Chest Physicians. Noninvasive staging of non-small cell lung cancer: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):178S-201S. doi: 10.1378/chest.07-1360.

De Leyn P, Lardinois D, Van Schil PE, Rami-Porta R, Passlick B, Zielinski M, Waller DA, Lerut T, Weder W. ESTS guidelines for preoperative lymph node staging for non-small cell lung cancer. Eur J Cardiothorac Surg. 2007 Jul;32(1):1-8. doi: 10.1016/j.ejcts.2007.01.075. Epub 2007 Apr 19.

Janes SM, Spiro SG. Esophageal endoscopic ultrasound/endobronchial ultrasound-guided fine needle aspiration: a new dawn for the respiratory physician? Am J Respir Crit Care Med. 2007 Feb 15;175(4):297-9. doi: 10.1164/rccm.200609-1390ED. No abstract available.

Navani N, Spiro SG, Janes SM. Mediastinal staging of NSCLC with endoscopic and endobronchial ultrasound. Nat Rev Clin Oncol. 2009 May;6(5):278-86. doi: 10.1038/nrclinonc.2009.39.

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