NCT04413409招募中不适用
A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-70 years old;
- •ECOG score: 0-2 points;
- •the expected life period is more than 3 months;
- •Histologically confirmed metastatic breast cancer: locations include central lung lesions, peripheral lung lesions or liver metastases;
- •PET-CT or other imaging showed patients with ≤3 metastastatic sites, involving 1-2 organs mentioned above, single lesion ≤5cm;
- •according to the RECIST 1.1 edition, there is at least one measurable lesion;
- •the main organs are functioning normally, meeting the following criteria: Blood routine: Hb > 90g/L (no blood transfusion within 14 days); ANC > 1.5 x 109/L; PLT > 75 * 109/L;Liver function: total bilirubin TBIL is less than 1.5 x ULN (upper limit of normal value); ALT and AST are less than 3 x ULN; if there is liver metastasis, ALT and AST are less than 5 x ULN;Renal function: serum creatinine < 1 x ULN;
- •participants voluntarily joined the study, signed informed consent, and followed up.
排除标准
- •the number of metastastatic sites ≥ 3, or the surgeon determines that the R0 resection cannot be achieved;
- •with metastatic lesions other than liver or lung
- •patients with local recurrence
- •palliative radiation therapy or interventional therapy have been performed previously for metastatic lesions
- •has received systemic treatment for metastatic disease, such as chemotherapy, targeted therapy, endocrine therapy, immunotherapy, etc.
- •pregnant or lactating women, women of childbearing age who cannot practice effective contraceptives;
- •involvement in clinical trials of unlisted drugs within 4 weeks before the start of this study;
- •severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;
结局指标
主要结局
Overall Survival
时间窗: 3-year
Overall survival is calculated from randomization to death from any cause
次要结局
- Time To Event (TTE)(From date of randomization at baseline to the time of the first event, assessed up to 60 months)
研究者
Zhimin Shao
Chief Physician
Fudan University
研究点 (1)
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