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NCT00859742 Clinical Trial

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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00859742
Other study ID # NCCTS-06-211
Secondary ID
Status Withdrawn
Phase N/A
First received March 10, 2009
Last updated March 29, 2018
Start date March 2009
Est. completion date August 2010

Study information
Verified date March 2018
Source National Cancer Center, Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of NCCKorea Goyang Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer. 1.5 years
Secondary The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer 1.5 years
Secondary The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy 1.5 years
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