Trial Information

A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

- Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA
non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection
or segmentectomy).

Secondary

- Compare the overall survival of patients undergoing lobectomy vs sublobar resection.

- Compare the rates of loco-regional and systemic recurrence in patients undergoing
lobectomy vs sublobar resection.

- Compare the pulmonary function of these patients, as measured by expiratory flow rates
at 6 months postoperatively.

- Explore the relationship between characteristics of the primary lung cancer, as
revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and
outcomes.

- Determine the false-negative rate of preoperative PET scan for identification of
involved hilar and mediastinal lymph nodes.

- Assess the utility of annual follow-up CT scan after surgical resection in these
patients.

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 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.

- Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic
surgery (VATS).

- Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open
thoracotomy or VATS.

After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually for 5 years.