Surgical Versus Non-surgical Staging of Lung Cancer

NCT01117714 | Terminated DMC

• 2 other identifiers: A-13245.8DOD
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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. 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.
2. 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.

Conditions

Lung Cancer

Keywords

Lung cancer; Lung neoplasm; Pulmonary cancer; Pulmonary neoplasm; Lung cancer staging

Outcome Measures

Primary Outcomes (1)

• Accuracy of each arm for the staging of lung cancer

  We will be testing whether or not the sensitivity of the EUS/EBUS technique for identifying malignant mediastinal lymph nodes is more than 10% worse than the sensitivity of the Mediastinoscopy technique. The primary analysis will be a direct comparison of the sensitivities of the 2 measures, where the sensitivity is defined as the number of true positive cases divided by the sum of the true positives and the false negatives, or the proportion of patients who truly have malignant mediastinal lymph nodes that test positive (i.e. via EUS/EBUS or Mediastinoscopy).

  Two years

Secondary Outcomes (1)

• Complication rates for each of the diagnostic strategies

  At 30 days or at the time of surgery, whichever is first.

Study Arms (2)

EUS/EBUS with FNA

ACTIVE COMPARATOR

EUS/EBUS staging will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. If present and accessible, at least one lymph node from each accessible station will be aspirated with a separate fine needle using routine FNA and cytological techniques. If multiple lymph nodes are present in a single station, the largest lymph node from that location will be sampled. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the staging procedures will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection.

Procedure: Integrated Staging for Early Detection of Metastases in Lung Cancer

Surgical Mediastinoscopy

ACTIVE COMPARATOR

Within two months following CT scan, surgical mediastinoscopy will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the diagnostic method (medical or surgical) used for staging will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection.

Procedure: Integrated Staging for Early Detection of Metastases in Lung Cancer

Interventions

Integrated Staging for Early Detection of Metastases in Lung Cancer PROCEDURE

To determine the accuracy of EBUS/EUS-guided FNA when compared with surgical mediastinoscopy/thoracoscopy

EUS/EBUS with FNA; Surgical Mediastinoscopy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Mayo Clinic: collaborator

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerard A Silvestri, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Brenda J Hoffman, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: May 5, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

US (3)