NCT06317324招募中不适用
A Prospective, Single Center, Observational Study:Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion.
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- LRFS
研究概览
简要总结
The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:
- Explore the survival differences.
- Explore of the lung function changes before and after different treatments.
详细描述
Main purpose:
Explore the survival differences between SBRT and surgery for NSCLC patients with interlobular pleural invasion.
Secondary purpose:
- Longitudinal exploration of the differences in heart and lung function changes before and after treatment between SBRT and surgery of NSCLC patients with interlobular pleural invasion
- Longitudinal exploration of dynamic changes in lung lobe volume before and after treatment in NSCLC patients with interlobular pleural invasion treated with SBRT and surgical intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and sign an informed consent form in writing;
- •Age 18 and above, regardless of gender;
- •Diagnosed as primary lung cancer through imaging/pathology, meeting the indications for SBRT and surgical treatment;
- •The clinical staging is cIB-IIIB stage (cT2-3N0M0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology;
- •Imaging diagnosis of NSCLC patients with tumor invasion of interlobular pleura;
- •No serious abnormalities in the blood system, heart, lungs, liver, kidney function, or immune deficiency;
- •There are no restrictions on surgical methods, and both VATS and open chest surgery are acceptable;
- •Physical condition score ECOG level 0-2;
- •Expected survival time>3 months.
排除标准
- •Pathological confirmation of small cell lung cancer;
- •Non solitary lung cancer, non primary lung cancer, with distant metastasis;
- •Individuals with a history of severe lung or heart disease;
- •Severe comorbidities, such as uncontrolled hypertension, heart failure, etc;
- •Pregnant or lactating women;
- •Previous history of malignant tumors;
- •Refusal or inability to sign the informed consent form for participating in the trial.
结局指标
主要结局
LRFS
时间窗: 3 years
Local Relapse Free Survival
PFS
时间窗: 3 years
Progression Free Survival
MRFS
时间窗: 3 years
Distant Metatasis Free Survival
OS
时间窗: 3 years
Overall Survival
次要结局
- FVC(1 year)
- PFR(1 year)
- VC(1 year)
- FEV1(1 year)
- DLCO(1 year)
研究者
研究点 (1)
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