Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- intracranial progress free survival rate
研究概览
简要总结
This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.
详细描述
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT
- •the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc.
- •KPS ≥60，or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas.
- •Age: 18-75 years old.
- •Adequate end-organ function:
- •WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range
排除标准
- •Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).
- •Unable or unwilling to comply with the study protocol.
- •The expected survival time is less than 3 months.
- •Patients who are anticipated in other clinical trials of brain metastases.
- •Patients who has been treated with SRT in other hospitals
- •Pregnant patients or female patients whose HCG is positive
- •Unsuitable to participate in study, that in the opinion of the treating physician.
研究组 & 干预措施
Refractory Brain Metastases
Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases
干预措施: Fractionated Stereotactic Radiotherapy (Radiation)
Refractory Brain Metastases
Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases
干预措施: Temozolomide (Drug)
结局指标
主要结局
intracranial progress free survival rate
时间窗: up to 2 years
defined as no progress of the treated lesions and no distant progress in the brain
次要结局
- Overall survival rate(up to 3 year)
- progress free survival rate(up to 1 year)
- local control rate(up to 1 year)
- disease control rate (DCR)(2-3 months after radiation)
- adverse event(from the day of radiation to the end of adjuvant TMZ，up to 6 months)
- causes of death(from the day of radiation to death date, up to 5 years)
研究者
Jianping Xiao
Dr
Chinese Academy of Medical Sciences