Clinical trial NCT01117714: Surgical Versus Non-surgical Staging of Lung Cancer
Official title: A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Lung neoplasm
Pulmonary cancer
Pulmonary neoplasm
Lung cancer staging
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2010-05-05
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph nodes are small glands found throughout the body that remove bacteria and foreign particles (part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the laboratory for testing. Biopsy results can determine if the cancer has spread (metastases) and to determine the best treatment for a patient with lung cancer.

The purpose of this study is to develop a better way to detect lung cancer earlier before it spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine needle aspiration (FNA) to see if either is better for this purpose. Traditional medical practice is to surgically open the chest and biopsy suspicious lymph nodes (called a mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest to stage and treat lung cancer.

Volunteers for this study have been diagnosed with known or suspected lung cancer, and will receive one of two choices to determine if their cancer has spread:

1. Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical procedure that allows physicians to view areas of the chest(including the heart, vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the trachea) tube is inserted followed by a small incision (cut) in the chest. A mediastinoscope is inserted through the incision to see the organs inside the mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or stage cancer.

   Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a very small incision in the chest wall. A thorascope is a thin, tube-like instrument with a light and lens which usually has a tool for removing tissue. This makes it possible to examine the lungs or other structures in the chest cavity, without making a large incision.
2. EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes can be obtained and a small needle can be guided through the esophagus into suspicious nodes to biopsy lymph nodes in the chest. Other research studies have shown that using EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS involves the use of a small ultrasound scope that is passed through the opening of the trachea and into the airways. EBUS combined with EUS is a less invasive procedure that provides full view of the lymph nodes in the chest area.


Eligibility criteria: Inclusion Criteria:

* Require either surgical or minimally invasive evaluation (EUS/EBUS) of the mediastinum
* Are medically fit to undergo surgery
* Possess known or suspected non-small cell carcinoma of the lung
* Have had PET/CT scan within 45 days of randomization
* Are eligible for complete mediastinal lymph node dissection at surgery if clinically indicated (determined at surgery)

Exclusion Criteria:

* Pathologically documented metastatic disease
* History of malignancy within 5 years other than (skin) basal cell carcinoma
* Bulky mediastinal lymphadenopathy defined as lymph node \> 2.0 cm in short axis diameter or contralateral adenopathy or direct invasion mediastinum or great vessels (T4 disease) or have a malignant pleural effusion.
* Peripheral T1 tumors with radiographically normal mediastinum on PET/CT.

Primary outcomes:
measure: Accuracy of each arm for the staging of lung cancer
timeFrame: Two years
Secondary outcomes:
measure: Complication rates for each of the diagnostic strategies
timeFrame: At 30 days or at the time of surgery, whichever is first.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Gerard A Silvestri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Brenda J Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References: