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

NCT00652769 | Completed Phase 3 DMC

• 1 other identifier: 07/0156
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Bronchogenic Carcinoma

Keywords

Lung; Cancer; Staging; Endobronchial; Ultrasound; Endoscopic

Outcome Measures

Primary Outcomes (1)

• Time from first outpatient appointment to decision to treat

  1 - 3 months

Secondary Outcomes (5)

• The healthcare costs for diagnosing and staging lung cancer

  End of study

• The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer

  1 - 3 months

• The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan

  1 - 3 months

• The time from first outpatient appointment to treatment

  1 - 3 months

• The number of futile thoracotomies

  1 - 3 years

Study Arms (2)

B

ACTIVE COMPARATOR

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.

Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy

A

EXPERIMENTAL

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.

Procedure: Endobronchial or Endoscopic Ultrasound

Interventions

Endobronchial or Endoscopic Ultrasound PROCEDURE

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.

Also known as: EBUS: Olympus Keymed BF-UC260F-OL8

A

Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy PROCEDURE

Investigations will be determined by the multi-disciplinary team responsible for the patient

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead
• North Middlesex University Hospital: collaborator
• Barnet and Chase Farm Hospitals NHS Trust: collaborator
• The Whittington Hospital NHS Trust: collaborator

Study Sites (4)

Barnet General Hospital

London, EN5 3DJ, United Kingdom

Location

North Middlesex University Hospital

London, N18 1QX, United Kingdom

Location

Whittington Hospital NHS Trust

London, N19 5NF, United Kingdom

Location

University College London Hospital NHS Trust

London, WC1E 6AU, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 11809983 BACKGROUND

• 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.

  PMID: 17873169 BACKGROUND

• 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.

  PMID: 17873168 BACKGROUND

• 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.

  PMID: 17448671 BACKGROUND

• 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.

  PMID: 17277288 BACKGROUND

• 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.

  PMID: 19390554 BACKGROUND

• Navani N, Nankivell M, Lawrence DR, Lock S, Makker H, Baldwin DR, Stephens RJ, Parmar MK, Spiro SG, Morris S, Janes SM; Lung-BOOST trial investigators. Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial. Lancet Respir Med. 2015 Apr;3(4):282-9. doi: 10.1016/S2213-2600(15)00029-6. Epub 2015 Feb 4.

  PMID: 25660225 DERIVED

MeSH Terms

Conditions

Carcinoma, Bronchogenic; Neoplasms

Interventions

Bronchoscopy; Magnetic Resonance Spectroscopy; Mediastinoscopy

Condition Hierarchy (Ancestors)

Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stephen Spiro, MD

  Univeristy College London NHS Trust

  PRINCIPAL INVESTIGATOR

• Sam Janes, MD PhD

  University College, London

  STUDY CHAIR

• Neal Navani, MD

  University College, London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Respiratory Medicine

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

GB (4)