Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- 3-year DFS
研究概览
简要总结
The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.
详细描述
Patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by MDT that are potential to reach no evidence of disease (NED) were included in our trial. All included patients receive para-aortic lymph node dissection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at enrollment is >= 18 and <= 75 years
- •ECOG PS 0-1
- •Histologically confirmed colorectal carcinoma
- •Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape.
- •Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
- •Adequate liver, renal and bona marrow function.
- •Signing written informed consent
排除标准
- •In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis.
- •Unable to achieve NED
- •Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months.
- •Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- •Organ transplantation requires immunosuppressive therapy
研究组 & 干预措施
Systemic therapy sequenced PALND
All received systemtic therapy (at most two lines).
干预措施: Para-aortic lymph node dissection (Procedure)
结局指标
主要结局
3-year DFS
时间窗: From date of recruiment until the date of disease recurrece, assessed up to 3 years
Time with no recurrence of the diseases.
次要结局
- 1-year DFS(From date of recruiment until the date of disease recurrece, assessed up to 1 years)
- LFS(From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years)
- 5-year OS(Up to 5 years)
研究者
Guosheng Wu
Chief physician
First Affiliated Hospital of Zhejiang University