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.
Procedure: segmentectomy or wedge resection
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer|
- disease-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- rate of loco-regional and systemic recurrence [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Primary Completion Date:||March 2021 (Final data collection date for primary outcome measure)|
Patients undergo a standard operation for lung cancer called a lobectomy.
Experimental: Arm B
Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
|Procedure: segmentectomy or wedge resection|
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.
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.
- To determine whether overall survival (OS) (after sublobar resection) is non-inferior to that after lobectomy.
- To determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499330
|Contact: Nasser Altorki, MD||212 746-5156|
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|Study Chair:||Nasser Altorki, MD||Weill Medical College of Cornell University|