NCT02301208Unknown3 期
A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
He Xia0 个研究点目标入组 120 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 主要终点
- Progress-free survival
研究概览
简要总结
This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed untreated NPC patients
- •T1-2N1-3M0 or T3-4NxM0
- •18-70 years old
- •with MRI examinations
- •With written consent
排除标准
- •With a second cancer
- •Pregnancy
- •With other severe diseases (blood,liver ,kidney or heart diseases)
- •Could not be staged properly
- •Without written consent
研究组 & 干预措施
High dose cisplatin arm
Active Comparator
concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
干预措施: Cisplatin (Drug)
Low dose cisplatin arm
Active Comparator
concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
干预措施: Cisplatin (Drug)
Low dose nedaplatin arm
Experimental
concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
干预措施: Nedaplatin (Drug)
High dose nedaplatin arm
Experimental
concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
干预措施: Nedaplatin (Drug)
结局指标
主要结局
Progress-free survival
时间窗: 2 years
Response rate
时间窗: 2 years
次要结局
- Overall survival(2 years)
- Tumor response(radiotherapy in 2 week、4 week、7 week)
研究者
He Xia
Jiangsu Cancer Hospital
Jiangsu Cancer Institute & Hospital
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