CompletedPhase 1 / Phase 2NCT00832715

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

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).

Checked against the public recordLast updated Jul 20, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations1
SponsorM.D. Anderson Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Procedure: EBUS-TBNA
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Patient must be \>/= 18 years old. 2. Patient must have Eastern Cooperative Oncology Group (ECOG)/Zubrod status 0-2. 3. 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). 4. Patient must be eligible for definitive surgical therapy for primary NSCLC. 5. Patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures. 6. 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. 7. All females of childbearing age must have a negative pregnancy test before beginning the study. Exclusion Criteria: 1. Patient has received prior chemotherapy or radiotherapy for this cancer. 2. Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options. 3. Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy. 4. Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology. 5. Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate). 6. Females who are pregnant and/or lactating.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2016. Always confirm current availability with the study team.

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