EBUS TBNA After PET/CT in Diagnosing Patients With Stage I-IIA Non-small Cell Lung Cancer Evaluated for Stereotactic Body Radiation Therapy

PRIMARY OBJECTIVES:

I. To assess the use of EBUS-TBNA after a PET/CT as a means of improving the accuracy of lymph node staging in patients considered for SBRT.

SECONDARY OBJECTIVES:

I. To assess the usefulness of PET/CT as a diagnostic test in identifying N1 versus N0 staging.

II. To compare survival and recurrence rates in patients with discordant PET/CT and EBUS-TBNA.

III. To describe EBUS-TBNA and SBRT related complications.

OUTLINE:

Patients undergo EBUS-TBNA before SBRT.

After completion of study, patients are followed up at 6 weeks, then every 3 months for the first 2 years then twice a year for the following 3 years, and annually thereafter.

Inclusion criteria

• Patient must be > 18 years old
• Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)
• Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA
• Patient is being considered for SBRT
• Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures
• If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a) Patient has undergone potentially curative therapy for all prior malignancies b) No evidence of active / recurrent disease within 5 years

Exclusion criteria

• Patient has received prior chemotherapy or radiotherapy for this cancer
• Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression)
• Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology
• Patients who are planning to undergo treatment in a different institution