Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases: A Prospective Multicenter Trial(TRACTS)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18 years old;
- •Tissue or cell pathological diagnosis of NSCLC;
- •Brain CT or MR validated BM;
- •Non-increased-intracranial-pressure symptomatic BM;
- •Haven't received TKI target treatment;
- •Haven't received brain radiotherapy;
- •Patients in initial treatment should be detected EGFR mutation;
- •Expected survival more than 6 months;
- •KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
- •Liver and kidney function requirements: SGOT/SGPT≦2.5 times of the upper limit, Total bilirubin≦1.5 times of the upper limit, serum Creatinine≦1.5 times of the upper limit;
- •Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L，no requirement for Hb;
- •Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
- •Female patients in childbearing age: HCG (-);
- •Patients signed an inform Consent.
排除标准
- •Those with Erlotinib drug allergies;
- •Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
- •Those without guardians or families;
- •Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
- •Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
- •Those with any other disease, neurological or metabolic dysfunction, and physical examination or laboratory test results showed that the study drugs may increase the risk of treatment-related complications;
- •Pregnant women.
研究组 & 干预措施
Erlotinib & secondary brain radiotherapy
Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
干预措施: Erlotinib (Drug)
Erlotinib & secondary brain radiotherapy
Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
干预措施: secondary brain radiotherapy (Radiation)
Erlotinib & concurrent brain radiotherapy
Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons
干预措施: Erlotinib (Drug)
Erlotinib & concurrent brain radiotherapy
Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons
干预措施: concurrent brain radiotherapy (Radiation)
结局指标
主要结局
overall survival
时间窗: 3.5year
次要结局
未报告次要终点
研究者
Yang Huan Jun
Fudan University
Fudan University