NCT00563927Unknown不适用
Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
Hospital Authority, Hong Kong4 个研究点 分布在 1 个国家目标入组 340 人开始时间: 1999年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 340
- 试验地点
- 4
- 主要终点
- Failure free survival rate
研究概览
简要总结
To test the therapeutic ratio of additional chemotheray on 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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undifferentiated or non-keratinizing carcinoma
- •Tumor staged as N2-3
- •No evidence of distant metastasis M0
- •Performance status:0-2
- •Marrow: WBC >= 4 and platelet >= 100
- •Renal: creatinine clearance >= 60
- •Informed consent
排除标准
- •WHO type I squamous cell carcinoma or adenocarcinoma
- •Age >= 70
- •Palliative intent or tumor extent mandating AP opposing facio-cervical fields
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
- •Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
- •Previous chemotherapy
- •Patient is pregnant or lactating
结局指标
主要结局
Failure free survival rate
时间窗: 5 year
次要结局
- Disease-specific survival rate(5-year)
- Overall survival rate(5-year)
- Complication-free rates(5-year)
研究者
研究点 (4)
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