A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 701
- 试验地点
- 386
- 主要终点
- disease-free survival
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-registration Eligibility Criteria:
- •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.
- •The tumor location must be suitable for either lobar or sublobar resection (wedge or segment).
- •ECOG performance status of 0-
- •No prior malignancy within 3 years other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix.
- •No prior chemotherapy or radiation therapy for this malignancy.
- •No evidence of locally advanced or metastatic disease.
- •Age ≥ 18 years
- •Intra-operative Randomization Eligibility Criteria:
- •Histologic confirmation of NSCLC (if not already obtained)
- •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.
排除标准
- 未提供
研究组 & 干预措施
Arm A
Patients undergo a standard operation for lung cancer called a lobectomy.
干预措施: lobectomy (Procedure)
Arm B
Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
干预措施: segmentectomy or wedge resection (Procedure)
结局指标
主要结局
disease-free survival
时间窗: Up to 7 years
次要结局
- overall survival(Up to 7 years)
- rate of loco-regional and systemic recurrence(Up to 7 years)
- pulmonary function as measured by expiratory flow rate 6 months postoperatively(at 6 months)