NCT06102161尚未招募3 期
Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent form and are willing to complete the study according to the plan;
- •Aged from 18 to 80 years old;
- •ECOG equals 0 or 1;
- •Not receiving lung cancer surgery before;
- •Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
- •Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
- •The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm;
- •peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.
- •cT1N0M0 tumors;
- •Complete tumor resection by wedge resection as assessed by the surgeon;
- •Not receiving chemotherapy or radiotherapy before.
排除标准
- •Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
- •CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
- •Cannot be completely resected by wedge resection;
- •Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;
- •Receiving lung cancer surgery before;
- •Receiving radiotherapy or chemotherapy.
研究组 & 干预措施
Wedge resection
Experimental
Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue.
干预措施: Wedge resection (Procedure)
结局指标
主要结局
5-year overall survival
时间窗: 5 years
The event is defined as the death due to any causes.
次要结局
- Postoperative lung function (FEV1)(5 years)
- Sites of tumor recurrence and metastasis(5 years)
- Radical wedge resection (R0 resection) completion rate(5 years)
- 5-year recurrence-free survival(5 years)
- Surgery-related complications(5 years)
- Postoperative lung function(5 years)
研究者
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University
研究点 (1)
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