NCT01171781Unknown2 期
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- progression free survival rate at 3 years
研究概览
简要总结
The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II ~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 ~2 good organ function (liver, renal, hematologic)
排除标准
- •active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
研究组 & 干预措施
3 weekly CDDP based CCRT
Active Comparator
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
干预措施: cisplatin (3 weekly) (Drug)
weekly cisplatin based CCRT
Experimental
radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
干预措施: cisplatin (weekly) (Drug)
结局指标
主要结局
progression free survival rate at 3 years
时间窗: 36 months
次要结局
- overall survival rate(36 months)
- objective response rate(36 months)
- toxicity(36 months)
- quality of life(36 months)
研究者
研究点 (1)
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