IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- CNS progression free survival
研究概览
简要总结
This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
详细描述
This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.
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
- •Pathologically confirmed NSCLC and wild type EGFR
- •4-10 brain metastases on high quality CT scanning or MRI.
- •No previous EGFR-TKI treatment.
- •No previous brain radiotherapy.
- •More than 4 weeks from last chemotherapy.
- •Expected Survival of at least 2 months.
- •RTOG RPA performance status 0-1
- •Lab tests should meet these criteria: White blood cell count ≥3×10^9 /L;Platelet count≥100×10^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
- •Pregnancy test (-)
- •Be able to sign informed consent form.
排除标准
- •With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases)
- •With metastases on meninges.
- •Taking antiepileptics (phenytoin sodium etc.) at the same time
- •Unable to oral medication.
- •Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
研究组 & 干预措施
IMRT & erlotinib
Patients in experimental group receive IMRT and erlotinib: Daily IMRT(45Gy in 15 fractions) to the brain metastases with daily erlotinib(150mg.po) for three weeks
干预措施: IMRT (Radiation)
IMRT & erlotinib
Patients in experimental group receive IMRT and erlotinib: Daily IMRT(45Gy in 15 fractions) to the brain metastases with daily erlotinib(150mg.po) for three weeks
干预措施: erlotinib (Drug)
whole-brain radiotherapy
Patients in this group receive WBRT at 30Gy in 10 fractions
干预措施: WBRT (Radiation)
结局指标
主要结局
CNS progression free survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
Hui Liu
Professor
Sun Yat-sen University