RECRUITINGINTERVENTIONAL

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)

About This Trial

It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 years or older 2. Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT 3. Performance status score (WHO/ECOG) of 0-2. 4. Cytological or histological proof of non-small cell cancer 5. Stage T1-2 disease, with no evidence of distant metastasis 6. Patients are screened by both computed tomography (CT) and positron emission tomography (PET) 7. Medically inoperable for surgical resection 8. Patients who refused surgery Who Should NOT Join This Trial: 1. Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy 2. Active systemic, pulmonary, or pericardial infection 3. Patients who are pregnant or lactating 4. Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression). 5. Inability to give willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age 18 years or older 2. Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT 3. Performance status score (WHO/ECOG) of 0-2. 4. Cytological or histological proof of non-small cell cancer 5. Stage T1-2 disease, with no evidence of distant metastasis 6. Patients are screened by both computed tomography (CT) and positron emission tomography (PET) 7. Medically inoperable for surgical resection 8. Patients who refused surgery Exclusion Criteria: 1. Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy 2. Active systemic, pulmonary, or pericardial infection 3. Patients who are pregnant or lactating 4. Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression). 5. Inability to give informed consent

Treatments Being Tested

PROCEDURE

EBUS-TBNA

Currently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT.

Locations (1)

Toronto General Hospital

Toronto, Ontario, Canada