NCT05717803招募中3 期
Segmentectomy for Ground Glass-dominant 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
- 307
- 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-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-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 ground glass-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 to 0.5, 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 0-0.5, 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
- 5-year overall survival(5 years)
- Lung function test(Half year and one year after surgical resection)
- Surgery-related complications(From surgery to patient discharge or 30 days after surgery.)
- 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.)
研究者
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University
研究点 (1)
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