Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- local control without symptomatic radiation necrosis rate
研究概览
简要总结
This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.
详细描述
This study plans to enroll 48 patients with 1-4 brain metastases with ≤2cm in diameter. All of the patients will receive FSRT with the dose of 30 Gy in 5 fractions. The primary endpoint is local control rate of asymptomatic brain necrosis at 1 year. The secondary endpoints include disease control rate at 2 months, local control rate at 1 year, intra-cranial distant failure at 1 year, overall survival rate at 1 year, toxicities, radiation necrosis rate, etc.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The primary tumor is proved malignant by pathology;
- •Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
- •The maximum diameter of each lesion is ≤ 2cm;
- •Age ≥ 18 years old;
- •Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT);
- •expected survival of more than 6 months;
- •The functions of vital organs meet the requirements;
- •The patients voluntarily join the clinical study and sign the informed consent.
排除标准
- •Surgical intervention is considered for MDT consultation;
- •Meningeal metastasis;
- •The primary tumor is small cell lung cancer;
- •Follow-up data can't be obtained regularly;
- •patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by color doppler examination;
- •neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months;
- •Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.
研究组 & 干预措施
fractionated stereotactic radiotherapy group
fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions.
干预措施: fractionated stereotactic radiotherapy (Radiation)
结局指标
主要结局
local control without symptomatic radiation necrosis rate
时间窗: 1 year after fractionated stereotactic radiotherapy (FSRT)
radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
次要结局
- adverse events(From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.)
- disease control rate(2 months after fractionated stereotactic radiotherapy (FSRT))
- local control rate(1 year after fractionated stereotactic radiotherapy (FSRT))
- intra-cranial distant failure rate(1 year after fractionated stereotactic radiotherapy (FSRT))
- intra-cranial progression free survival rate(1 year after fractionated stereotactic radiotherapy (FSRT))
- radiation necrosis rate(From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.)
研究者
YE ZHANG
Dr.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences