Status:
COMPLETED
Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 w...
Detailed Description
Study Procedures: A procedure called EBUS-TBNA has been developed that might allow doctors to get samples of lymph glands without performing an operation. The standard practice is a surgical operatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00832715
Start Date
April 1 2009
End Date
July 1 2016
Last Update
July 20 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030