Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This is a study from Eastern Cooperative Thoracic Oncology Project, numbered as ECTOP-1009. Systematically mediastinal lymph node dissection or not in clinical stage T1 ground-glass dominated invasive lung adenocarcinoma: a multi-center, prospective clinical trial
详细描述
Following interim analysis of 302 patients revealed no lymph node metastasis in either study arm and 100% 2-year disease-free survival in both arms. The selective non-mediastinal lymph node dissection (non-SLND) arm had reduced complications (JCO 2025; doi:10.1200/JCO-25-00610). The study design has been amended to a single-arm prospective cohort. All enrolled patients meeting inclusion criteria will sign informed consent and receive non-SLND. The primary endpoint remains 3-year disease-free survival (DFS).
The sample size has been recalibrated to 545 patients based on historical control 3-year DFS of 96.6%, a stricter non-inferiority margin of 2.5%, 90% power, and the 1-sided alpha of 2.5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Treatment groups will be open to both patients and surgeons.
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
- •Clinical stage T1N0M0 and planned curative surgery.
- •A single lesion detected on computed tomography (CT) scan featured as ground glass nodule(GGO) and C/T ratio ≤0.
- •Age 18 to
- •Patients who have signed the informed consent form.
排除标准
- •Other than invasive adenocarcinoma by pathological analysis.
- •Patients undergoing wedge resection but not meeting the specific conditions of a Consolidation/Tumor Ratio (CTR) ≤ 0.25 AND a maximum tumor diameter ≤ 2 cm, based on the oncological outcomes of the JCOG0804/WJOG4507L trial.
- •Not complete resected or curative intent.
- •Patients who have history of other malignant tumors.
- •Patients who have history of thoracic surgery.
- •Patients who have received radiation, chemotherapy or other treatments previously.
结局指标
主要结局
Disease-free survival
时间窗: 3 years after the surgery
Disease-free survival means the period after surgery when no disease can be detected.
次要结局
- Overall survival(3 years after the surgery)
- Rate of patients with perioperative complications(1 month after the surgery)
- Overall survival(3 years after the surgery)
- Rate of patients with perioperative complications(1 month after the surgery)