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: 2024年4月26日

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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

Second Affiliated Hospital, School of Medicine, Zhejiang University

申办方类型

Other

责任方

Sponsor

研究点 (2)

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