Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- 2-year incidence of brain metastases
研究概览
简要总结
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.
详细描述
We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of small-cll lung cancer histology
- •18 years or older
- •Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- •Local stage SCLC without distant metastases
- •After 1st-line chemotherapy (EP or IP) at least 4 cycles
- •After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
- •CR or PR assessment by RECIST(1.0) before randomized
- •Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- •Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- •Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
排除标准
- •Mixed non-small cell lung cancer histology
- •Neck and supraclavicular lymph node metastasis
- •Be allergic to temozolomide or intolerable to radiotherapy
- •Any unstable systemic disease
- •Pregnant or lactating women
研究组 & 干预措施
temozolomide
temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
干预措施: temozolomide (Drug)
prophylaxis cranial radiotherapy
prophylaxis cranial radiotherapy,25-30Gy/10Fra
干预措施: prophylaxis cranial radiotherapy (Radiation)
结局指标
主要结局
2-year incidence of brain metastases
时间窗: 2 year
次要结局
未报告次要终点
研究者
Haihong Yang, MD, Pricipal investigator
Associate Chief Physician
Guangzhou Medical University