NCT01102517Unknown不适用
A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年1月1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
- 500
- 试验地点
- 1
- 主要终点
- Disease-free survival and overall survival
研究概览
简要总结
The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer.
The aims of this study are:
- To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
- To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
- To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
- To explore the indication of VATS lobectomy for the lung cancer.
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
- Single (Outcomes Assessor)
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
- •Early stage NSCLC and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (CT) scan;
- •No medical contraindications to lung resection
- •Age ≤ 75 years old and ≥18 years old;
- •Sign the informed consent form.
排除标准
- •Evidence of invasion into neighboring organs;
- •Extensive pleura adhesion;
- •Central lesion;
- •Not suitable for single-lung ventilation;
- •Had history of thoracotomy and radiation for thoracic region ;
- •Pregnancy or lactation female patients;
- •Cannot sign the informed consent form because of psychological, family and society factors;
- •Had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate;
- •Participants can not accept operation for other uncontrolled factors.
研究组 & 干预措施
VATS group
Experimental
video-assisted thoracoscopic surgery
干预措施: video-assisted thoracoscopic surgery (Procedure)
axillary thoracotomy
Other
Control group
干预措施: axillary thoracotomy (Procedure)
结局指标
主要结局
Disease-free survival and overall survival
时间窗: 5 years
次要结局
- Perioperation data(perioperation)
- Cytokines response(the first 48 hours after the surgery)
- Quality of life(the first year after the surgery)
- Postoperative pulmonary function(the first three months after the surgery)
- Postoperative Karnofsky performance status(the first year after the surgery)
- Postoperative Chest Pain(the first year after the surgery)
研究者
Hao Long
Sun Yat-sen University Cancer Center
Sun Yat-sen University
研究点 (1)
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