Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,362
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
详细描述
The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis;
- •Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery;
- •No history of malignancies within past 5 years or lung surgery;
- •No anti-cancer treatment prior to surgery.
排除标准
- •Simultaneous or metachronous (within the past 5 years) double cancers;
- •Active bacterial or fungous infection;
- •Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema;
- •Systemic steroidal medication;
- •Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
结局指标
主要结局
Overall survival
时间窗: 5 years
Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive.
次要结局
- Relapse-free survival(5 years)
- Duration of hospitalization(1-60 days)
- Duration of chest drainage tube placement(1-60 days)
- Operation time(20-180 minutes.)
- Blood loss(1-60 days)
- Proportion of local recurrence(5 years)