NCT05129774尚未招募不适用
Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 5-year OS
研究概览
简要总结
In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 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 left-sided colon and rectal carcinoma
- •synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
- •patients potential to receive surgery and achieve no evidence of disease (NED)
- •able to tolerate surgery
- •providing written informed consent
排除标准
- •local invasion or distant metastasis other than para-aoritc lymph nodes
- •history of other malignant tumor
- •coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
- •emergency surgery
结局指标
主要结局
5-year OS
时间窗: From date of recruitment until the date of death from any cause, assessed up to 5 years
5-year overall survival
次要结局
- Postoperative complications(From date of surgery until the date of 30 days after surgery)
- LFFS(From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years)
- DFS(From date of recruitment until the date of disease recurrece, assessed up to 5 years)
研究者
研究点 (1)
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