Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment ebus-tbna, integrated pet/ct
Sponsor National Cancer Center, Korea
Start date March 2009
End date August 2010
Trial size 40 participants
Trial identifier NCT00859742, NCCTS-06-211

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.

Primary Outcomes

Measure
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

Measure
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
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
time frame: 1.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Bin Hwangbo, MD. PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.