NCT00190554终止3 期
A Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 330
- 试验地点
- 48
- 主要终点
- Disease free survival
研究概览
简要总结
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma
详细描述
The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven squamous cell carcinoma of the thoracic esophagus
- •pathologic stages IIa, IIb, III except T4
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •no previous history of chemotherapy nor radiotherapy
- •an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr
- •oral or written informed consent obtained before randomization
排除标准
- •severe heart diseases
- •uncontrollable hyper tension or diabetes mellitus
- •severe pulmonary dysfunction
- •HBs positive
- •active bacterial infection
- •synchronous or metachronous (within 5 years) malignancy
- •pregnant female
- •psychiatric medication
结局指标
主要结局
Disease free survival
时间窗: year
次要结局
- Toxicity of chemotherapy(year)
- Overall survival(year)
- Operative morbidity(year)
研究者
研究点 (48)
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