NCT02385136Unknown1 期
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases: A Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 135
- 主要终点
- Time to central nervous system progress which was confirmed by MRI
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically diagnosed as NSCLC, stage IVb [ (American Joint of Cancer Committee(AJCC), 2002) ], Brain metastasis
- •no history of hypertension or diabetes.
排除标准
- •the brain tumor diameter >5cm; RPA class =3; pregnancy.
研究组 & 干预措施
WBRT plus TMZ arm
Experimental
whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ)
干预措施: Temozolomide (Drug)
结局指标
主要结局
Time to central nervous system progress which was confirmed by MRI
时间窗: 1 to 24 months post procedure
objective response rate
时间窗: 1 month post procedure
次要结局
- Overall Survival(1 to 24 months post procedure)
- The Quality of Life(0 to 24 months post procedure)
- Toxicity as measured by CTCAE V4.0(0 to 24 months post procedure)
研究者
chenjianxiang
Dr Chen
Zhejiang Cancer Hospital
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