Trial Information

Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study

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.