CLINICAL TRIAL / NCT00499330

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Interventional
Active
NCT00499330

Eligibility Details Visit Clinicaltrials.gov

Contact Information

A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral 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.

Detailed Description

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.

Eligibility Details

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers
No

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.