NCT06634966招募中3 期
Segmentectomy for Solid-dominant GGO-featured Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- 5-year disease-free survival
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for solid-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:
- The 5-year disease-free survival of patients having solid-dominant invasive lung cancer with size of 2-3cm;
- The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.
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;
- •Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
- •Ground glass-dominant lung nodules
- •Consolidation-to-tumor ratio (CTR) ranges from 0.5 to 1, and tumor size ranges from 2 to 3cm;
- •cN0 without distant metastasis;
- •Tumors could be completely resected assed by surgeons;
- •Not receiving chemotherapy or radiotherapy before.
排除标准
- •CTR is not 0.5-1, or size is not 2-3cm;
- •Tumors could not be completely resected assed by surgeons;
- •Not lung adenocarcinoma diagnosed cytologically or pathologically;
- •Receiving lung cancer surgery before;
- •Receiving radiotherapy or chemotherapy.
结局指标
主要结局
5-year disease-free survival
时间窗: 5 years
The event is defined as the tumor recurrence or the death due to any causes.
次要结局
- Lung function test(Half year and one year after surgical resection)
- 5-year overall survival(5 years)
- The site of tumor recurrence and metastasis(From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.)
- Segmentectomy completion rate(From the beginning of the surgery to the end of the surgery.)
- Radical segmentectomy (R0 resection) completion rate(From surgery to the release of the final pathology report, an average of two weeks.)
- Surgery-related complications(From surgery to patient discharge or 30 days after surgery.)
研究者
研究点 (1)
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