NCT02879227已完成2 期
Phase II of Radiochemotherapy in Elderly Patients With Oesophagus 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
- 23
- 主要终点
- Feasibility of treatment: Number of patients with completed treatment
研究概览
简要总结
Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.
详细描述
Phase II study of radiochemotherapy for elderly patients with oesophagus cancer with Radiotherapy = 50 Gy, 2Gy/f ans chemotherapy with 2 arms arm Cisplatin = Cisplatin 75mg/m2 J1J22 or arm Oxaliplatine = oxaliplatine 85mg/m2 every 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat
排除标准
- •previous radiotherapy
- •no fit to treat
研究组 & 干预措施
Arm Cisplatin
Active Comparator
Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2)
干预措施: Cisplatin (Drug)
Arm Oxaliplatin
Experimental
Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6)
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Feasibility of treatment: Number of patients with completed treatment
时间窗: 6 weeks after end of the radiochemotherapy
number of patient with completed treatment
次要结局
- Tumoral response(6 weeks after end of the radiochemotherapy)
- Quality of life(6 weeks after end of the radiochemotherapy)
研究者
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