NCT00154804已完成2 期
A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical and pathological response rates
研究概览
简要总结
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
详细描述
The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven SCC or adenocarcinoma of esophagus .
- •Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
- •M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
- •Age ≧ 18 ys
- •Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl .
排除标准
- •Invasion to surrounding organ ( T4 disease ) .
- •Distant metastasis , except M1a disease .
- •Patients who refuse operation .
研究组 & 干预措施
A
Experimental
干预措施: Paclitaxel, Cisplatin,Surgery, CCRT (Drug)
结局指标
主要结局
Clinical and pathological response rates
时间窗: 2000~2004
次要结局
- Progression free survival(2000~2004)
- overall survival(2000~2004)
- Toxicity(2000~2004)
研究者
研究点 (1)
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