Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)

Completed · Phase 1/Phase 2

Conditions studied: Lung Cancer

In brief

The goal of this clinical research study is to learn how accurately an endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT00832715

Run by

M.D. Anderson Cancer Center

People needed

120

Starts

2009-04-01

Expected to finish

2016-07-01

Last updated by the study team

2016-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be >/= 18 years old.
• Patient must have Eastern Cooperative Oncology Group (ECOG)/Zubrod status 0-2.
• Patient must have proven or suspected NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1).
• Patient must be eligible for definitive surgical therapy for primary NSCLC.
• Patient or the patient's legally acceptable 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.
• All females of childbearing age must have a negative pregnancy test before beginning the study.

You may not qualify if…

• Patient has received prior chemotherapy or radiotherapy for this cancer.
• Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
• Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
• Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
• Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).
• Females who are pregnant and/or lactating.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.