Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00499330|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2007
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: lobectomy Procedure: segmentectomy or wedge resection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||701 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||March 2021|
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|
- disease-free survival [ Time Frame: Up to 7 years ]
- overall survival [ Time Frame: Up to 7 years ]
- rate of loco-regional and systemic recurrence [ Time Frame: Up to 7 years ]
- pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Time Frame: at 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499330
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|Study Chair:||Nasser Altorki, MD||Weill Medical College of Cornell University|