NCT06385717招募中不适用
Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of toxic events
研究概览
简要总结
This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.
详细描述
Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection；
- •No definite contraindications for chemo-radiotherapy；
- •Informed consent has been signed；
- •Refused surgery after endoscopic submucosal dissection.
排除标准
- •Severe heart, brain, lung disease or renal dysfunction;
- •Previous history of other malignancies;
- •Prior radiation or chemotherapy
- •Researchers consider it inappropriate to participate in this experiment
结局指标
主要结局
Incidence of toxic events
时间窗: 2026.2
esophageal stenosis, radiation pneumonitis, etc
次要结局
- 3-year local-regional recurrence free survival(2029.1)
- 3-year overall survival(2029.1)
研究者
研究点 (2)
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