Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for the Mediastinal Re-staging After Induction Therapy in Non-small Cell Lung Cancer. A Prospective Study

National Cancer Center, Korea1 site in 1 countryMarch 2009

ConditionsNon Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non Small Cell Lung Cancer
Sponsor: National Cancer Center, Korea
Locations: 1
Primary Endpoint: The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

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:

To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging
To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
To determine procedure related complications

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

August 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Center, Korea

Responsible Party

Principal Investigator

Bin Hwangbo

Principal Investigator

National Cancer Center, Korea

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer(1.5 years)
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy(1.5 years)