NCT05327517招募中不适用
Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2022年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
- •Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
- •Aged 18-75 years;
- •Without any contraindication of operation;
- •Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN;
- •Without other malignancies;
- •Expected R0 resection;
- •ECOG PS 0-1;
- •Volunteered to participate in the study, signed the informed consent form.
排除标准
- •Without other malignancies;
- •With mental diseases;
- •With hemorrhagic disease;
- •Inoperable patients;
- •Pregnant or lactating women;
- •Has a history of allergy to paclitaxel or cisplatin
结局指标
主要结局
Overall Survival
时间窗: 5 years after surgery or definitive Chemoradiotherapy is completed
5 year overall survival
次要结局
- Laryngo-esophageal dysfunction free survival(5 years after surgery or definitive Chemoradiotherapy is completed)
研究者
研究点 (1)
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