AzTrials
AzTrials

Bronchogenic CarcinomaPhase 3BOOSTNCT00652769

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

A Phase 3 study testing Endobronchial or Endoscopic Ultrasound and Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy in people with Bronchogenic Carcinoma, run by University College London Hospitals at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchogenic Carcinoma
What is being tested?
Endobronchial or Endoscopic Ultrasound and Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
4 sitesUnited Kingdom
Study dates
Mar 2008to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

  • Barnet General Hospital

    London, EN5 3DJ

  • North Middlesex University Hospital

    London, N18 1QX

  • Whittington Hospital NHS Trust

    London, N19 5NF

  • University College London Hospital NHS Trust

    London, WC1E 6AU

Other trials in United Kingdom

About this study

Official title: A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer

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.

Being tested
Endobronchial or Endoscopic Ultrasound, Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Keywords
Lung, Cancer, Staging, Endobronchial, Ultrasound, Endoscopic
Medical subject headings
Carcinoma, Bronchogenic, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endobronchial or Endoscopic UltrasoundProcedure or surgery

    Also called EBUS: Olympus Keymed BF-UC260F-OL8

    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.

  • Bronchoscopy, CT-guided biopsy, PET scan, MediastinoscopyProcedure or surgery

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

Study groups in NCT00652769
Study groupRoleWhat they receive
BActive comparatorControl 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.
Receives: Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
AExperimentalActive 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.
Receives: Procedure: Endobronchial or Endoscopic Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from first outpatient appointment to decision to treat

    Measured: 1 - 3 months

Secondary outcomes (5)

  1. The healthcare costs for diagnosing and staging lung cancer

    Measured: End of study

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

    Measured: 1 - 3 months

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

    Measured: 1 - 3 months

  4. The time from first outpatient appointment to treatment

    Measured: 1 - 3 months

  5. The number of futile thoracotomies

    Measured: 1 - 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionSep 2011
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00652769
Sponsor's protocol ID
07/0156
Acronym
BOOST
Status last verified
Oct 2017
First submitted
1 Apr 2008
Last updated
1 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11809983

  • 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.

    PubMed 17873169

  • 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.

    PubMed 17873168

  • 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.

    PubMed 17448671

  • 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.

    PubMed 17277288

  • 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.

    PubMed 19390554

  • 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.

    PubMed 25660225

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endobronchial or Endoscopic Ultrasound and Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy in people with Bronchogenic Carcinoma, run by University College London Hospitals at 4 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from first outpatient appointment to decision to treat (time frame: 1 - 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00652769, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.

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