NCT03108560Unknown不适用
A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年4月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cT1N0M0 non-small-cell lung cancer
- •ground-glass opacity, ≤2cm, GGO≥25%
- •eligible for both lobectomy and sublobar resection
- •intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma
- •intraoperative pathology of biopsied station 10 lymph node is negative
排除标准
- •intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ
- •intraoperative pathology of biopsied station 10 lymph node is positive
- •multiple GGOs, lesions other than dominant lesion are malignant or >5mm
- •history of thoracic surgery
- •history of malignancy in recent 5 years
- •unstable systemic disease
- •patients with psychiatric disorders
研究组 & 干预措施
Sublobar group
Experimental
Patients receive sublobar resection, including wedge resection and segmentectomy.
干预措施: sublobar resection (Procedure)
Lobectomy group
Active Comparator
Patients receive lobectomy.
干预措施: lobectomy (Procedure)
结局指标
主要结局
Overall Survival
时间窗: five years after surgery
survival status of patients after surgery
次要结局
- Disease Free Survival(five years after surgery)
- Local and distant recurrence rates(five years after surgery)
- Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter(3rd, 6th, 12th, and 24th month after surgery)
- Pulmonary Function: forced vital capacity (FVC) in liter(3rd, 6th, 12th, and 24th month after surgery)
- Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg(3rd, 6th, 12th, and 24th month after surgery)
- Morbidity rate(up to 30 days after surgery)
- Mortality rate(up to 30 days after surgery)
研究者
研究点 (1)
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