Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer
RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.
Procedure: therapeutic thoracoscopy
Procedure: video-assisted surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study|
|Study Start Date:||December 1998|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.
OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.
PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003692
Show 115 Study Locations
|Study Chair:||Scott J. Swanson, MD||Dana-Farber/Brigham and Women's Cancer Center|
|Study Chair:||John R. Roberts, MD, MBA||Vanderbilt-Ingram Cancer Center|