OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
tumor size (< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension
determined from the preoperative CT scan), histology (squamous cell carcinoma vs
adenocarcinoma vs other), and smoking status (never smoked [smoked < 100 cigarettes over
lifetime] vs former smoker [smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current
smoker [quit < 1 year ago or currently smokes]). Patients are randomized to 1 of 2
treatment arms. For more information, please see the Arms section.
Primary Objective:
To determine whether DFS after sublobar resection (segmentectomy or wedge) is
non-inferior to that after lobectomy in patients with small peripheral (≤ 2 cm) NSCLC.
Secondary Objectives:
1. To determine whether overall survival (OS) (after sublobar resection) is
non-inferior to that after lobectomy.
2. To determine the rates of loco-regional and systemic recurrence (exclusive of second
primaries) after lobar and sublobar resection.
3. To determine the difference between the two arms of the study in pulmonary function
as determined by expiratory flow rates measured at 6 months post-operatively.
4. Imaging Substudy: To explore the relationship between characteristics of the primary
lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a
determination of the false-negative rate of the pre-operative PET scan for
identification of involved hilarand mediastinal lymph nodes; and an assessment of
the utility of annual follow-up CT imaging after surgical resection of small stage
IA NSCLC.
After completion of study treatment, patients are followed up every 6 months for 2 years
and then annually for 5 years.
