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Non-small Cell Lung CancerNCT01146366

Utility of Routine Cervical Mediastinoscopy in Clinical Stage I Non-Small Cell Lung Cancer (NSCLC)

An observational study of Non-small Cell Lung Cancer, run by Jennifer Bell at 4 sites in United States.

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

To prospectively look at the utility of routine cervical mediastinoscopy (lymph node biopsy) in patients with clinically staged T2N0M0 NSCLC, as well as patients with clinically staged T1N0M0 NSCLC with a high maxSUV of the primary tumor on PET imaging. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
How many people
111 participants
Where
4 sitesUnited States
Study dates
Jan 2008to Dec 2014
Phase
Observational
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

Study population: Patients being evaluated by a thoracic surgeon for surgical resection of clinical stage I non-small cell lung cancer

Who may be able to join

  • Patients must have proven or suspected clinical stage I NSCLC. Clinical stage IA (T1N0M0) patients are only allowed participation if the maxSUV of the primary tumor is >/=10. Clinical stage IB (T2N0M0) must be by size criterion only (i.e. the tumor must be > 3cm in size. Patients that have T2 tumors by visceral pleural involvement only are not eligible for the study).
  • Patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach).
  • Patient must have an ECOG/Zubrod score of 0, 1 or 2.
  • Patients must not have undergone previous invasive mediastinal staging for this cancer.
  • Patients must not have a tracheostomy.
  • Patient must have a CT of the chest and upper abdomen or an FDG-PET scan performed within 60 days of enrollment to the study that confirms their clinical stage I status. Both scans must be performed, only one needs to be within 60 days of enrollment to the study.

Who cannot join

  • There are no separately noted exclusion criteria. All criteria are listed under inclusion.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27509

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Utility of Routine Cervical Mediastinoscopy in Clinically Staged T2N0M0 and Select T1N0M0 Non-Small Cell Lung Cancers by FDG-PET and CT Scans

To prospectively look at the utility of routine cervical mediastinoscopy (lymph node biopsy) in patients with clinically staged T2N0M0 NSCLC, as well as patients with clinically staged T1N0M0 NSCLC with a high maxSUV of the primary tumor on PET imaging.

Hypothesis #1: The prevalence of mediastinal lymph node metastases detectable by cervical mediastinoscopy is sufficiently low (<10%) to not support the routine use of this test in the study population.

Hypothesis #2: The preoperative detection of occult(hidden) N2 lymph node metastases by cervical mediastinoscopy in patients with clinically staged T2N0M0 NSCLC or T1N0M0 NSCLC with maxSUV >10 on PET does not provide a survival benefit when compared to detection of occult N2 lymph node metastases at the time of thoracotomy using nodal dissection or systematic sampling.

Keywords
Early stage lung cancer, Cervical mediastinoscopy, Observational study, clinical stage T2N0M0 and select T1N0M0 (suvMAX on FDG-PET of >/=10)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

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

  1. Prevalence of occult N2/3 metastases in the study population

    Prevalence of occult N2/3 metastases in the study population. This is the fraction of enrolled patients with N2/3 metastases detected by either mediastinoscopy or by systematic sampling/dissection.

    Measured: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.

Secondary outcomes (1)

  1. Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases

    Sensitivity of cervical mediastinoscopy for clinically occult N2 metastases. This is the number of patients with positive mediastinoscopy divided by the total number with N2/3 disease detected by either mediastinoscopy or by systematic sampling/dissection.

    Measured: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.

Timeline

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

  1. First posted17 Jun 2010 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146366
Sponsor's protocol ID
08-0020
Status last verified
Dec 2014
First submitted
10 Jun 2010
Last updated
11 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Meyers BF, Haddad F, Siegel BA, Zoole JB, Battafarano RJ, Veeramachaneni N, Cooper JD, Patterson GA. Cost-effectiveness of routine mediastinoscopy in computed tomography- and positron emission tomography-screened patients with stage I lung cancer. J Thorac Cardiovasc Surg. 2006 Apr;131(4):822-9; discussion 822-9. doi: 10.1016/j.jtcvs.2005.10.045. Epub 2006 Mar 2.

    PubMed 16580440

  • Reed CE, Harpole DH, Posther KE, Woolson SL, Downey RJ, Meyers BF, Heelan RT, MacApinlac HA, Jung SH, Silvestri GA, Siegel BA, Rusch VW; American College of Surgeons Oncology Group Z0050 trial. Results of the American College of Surgeons Oncology Group Z0050 trial: the utility of positron emission tomography in staging potentially operable non-small cell lung cancer. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1943-51. doi: 10.1016/j.jtcvs.2003.07.030.

    PubMed 14688710

  • Hammoud ZT, Anderson RC, Meyers BF, Guthrie TJ, Roper CL, Cooper JD, Patterson GA. The current role of mediastinoscopy in the evaluation of thoracic disease. J Thorac Cardiovasc Surg. 1999 Nov;118(5):894-9. doi: 10.1016/s0022-5223(99)70059-0.

    PubMed 10534695

  • Gonzalez-Stawinski GV, Lemaire A, Merchant F, O'Halloran E, Coleman RE, Harpole DH, D'Amico TA. A comparative analysis of positron emission tomography and mediastinoscopy in staging non-small cell lung cancer. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1900-5. doi: 10.1016/s0022-5223(03)01036-5.

    PubMed 14688703

  • Cerfolio RJ, Bryant AS, Ohja B, Bartolucci AA. The maximum standardized uptake values on positron emission tomography of a non-small cell lung cancer predict stage, recurrence, and survival. J Thorac Cardiovasc Surg. 2005 Jul;130(1):151-9. doi: 10.1016/j.jtcvs.2004.11.007.

    PubMed 15999056

  • Fernandez FG, Kozower BD, Crabtree TD, Force SD, Lau C, Pickens A, Krupnick AS, Veeramachaneni N, Patterson GA, Jones DR, Meyers BF. Utility of mediastinoscopy in clinical stage I lung cancers at risk for occult mediastinal nodal metastases. J Thorac Cardiovasc Surg. 2015 Jan;149(1):35-41, 42.e1. doi: 10.1016/j.jtcvs.2014.08.075. Epub 2014 Sep 17.

    PubMed 25439769

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer, run by Jennifer Bell at 4 sites in United States.

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 6 inclusion and 1 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 11 Dec 2014. 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 States. 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.

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?

Prevalence of occult N2/3 metastases in the study population (time frame: After cervical mediastinoscopy is performed in all subjects, estimated completion of enrollment of all subjects is 12/2012.). 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 NCT01146366, which also lists 6 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 11 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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