A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer
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.
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:
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:
Intra-operative Randomization Eligibility Criteria:
Burbank, California 91505, United States
Sacramento, California 95817, United States
Aurora, Colorado 80045, United States
East China, Michigan 48054, United States
Gorsse Pointe Woods, Michigan 48236, United States
Grosse Pointe Woods, Michigan 48236, United States
Rochester Hills, Michigan 48309, United States
Warren, Michigan 48093, United States
West Branch, Michigan 48661, United States
Basking Ridge, New Jersey 07920, United States
East Syracuse, New York 13057, United States
East White Plains, New York 10604, United States
Spartanburg, South Carolina 29307, United States
American Fork, Utah 84003, United States
Berlin Corners, Vermont 05602, United States
Yakima, Washington 98902, United States
Québec, Quebec G1V 4G5, Canada