Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than
 lobectomy for non-small cell lung cancer and may have fewer side effects and improve
 recovery. It is not yet known whether wedge resection or segmentectomy are more effective
 than lobectomy in treating stage IA non-small cell lung cancer.

 PURPOSE: This randomized phase III trial is studying different types of surgery to compare
 how well they work in treating patients with stage IA non-small cell lung cancer.
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.
Pre-registration Eligibility Criteria:

 1. Peripheral lung nodule ≤ 2 cm on preoperative CT scan and presumed to be lung cancer.
 The center of the tumor, as seen on CT, must be located in the outer third of the lung
 in either the transverse, coronal or sagittal plane. Patients with pure ground glass
 opacities or pathologically confirmed N1 or N2 disease are not eligible.

 2. The tumor location must be suitable for either lobar or sublobar resection (wedge or
 segment).

 3. ECOG performance status of 0-2.

 4. No prior malignancy within 3 years other than non-melanoma skin cancer, superficial
 bladder cancer, or CIS of the cervix.

 5. No prior chemotherapy or radiation therapy for this malignancy.

 6. No evidence of locally advanced or metastatic disease.

 7. Age ≥ 18 years

 Intra-operative Randomization Eligibility Criteria:

 1. Histologic confirmation of NSCLC (if not already obtained)

 2. Confirmation of N0 status by frozen section examination. Right sided tumors require
 that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section.
 Left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed
 as negative on frozen section. Levels 4 and 7 nodes may be sampled by mediastinoscopy,
 endobronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS), or at the time of
 thoracotomy or VATS exploration. Nodes previously sampled by mediastinoscopy (or EBUS
 and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical
 procedure (thoracotomy or VATS) do not need to be resampled.