Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-Staging of Non-Small Cell Lung Cancer (NSCLC)

Verified by: National Cancer Center, Korea, March 2009
First Received: March 10, 2009 | Last Updated: March 10, 2009 | Phase: N/A | Start Date: March 2009
Overall Status: Active, not recruiting | Estimated Enrollment: 40
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The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer. Primary objective: 1. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after...

Brief Summary

Official Title: “Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for the Mediastinal Re-Staging After Induction Therapy in Non-Small Cell Lung Cancer. A Prospective Study”

The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer.

Primary objective:

1. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment.

Secondary objectives:

1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging

2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy

3. To determine procedure related complications

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

  • Procedure: EBUS-TBNA, integrated PET/CT
    • EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: EBUS-TBNA

Outcome Measures for this Clinical Trial

Primary Measures

  • The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
    • Time Frame: 1.5 years
      Safety Issue?: No

Secondary Measures

  • The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer
    • Time Frame: 1.5 years
      Safety Issue?: No
  • The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
    • Time Frame: 1.5 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Histologically proven non-small cell lung cancer
  • Patients who have initially histologically proven N2 disease (Stage IIIA)
  • Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
  • Written informed consent

Exclusion Criteria:

  • Contraindications for bronchoscopy
  • Medically inoperable patients
  • Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: National Cancer Center, Korea Other

Overall Clinical Trial Officials and Contacts

Bin Hwangbo, MD. PhD Principal Investigator Goyang, Gyeonggi-do, Korea, Republic of  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00859742

Study ID Number: NCCTS-06-211

ClinicalTrials.gov Identifier: NCT00859742

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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