A Phase II Pilot Study of Fractionated Stereotactic Radiotherapy(FSRT) in Breast Cancer Patients With 1 to 10 Brain Metastases
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- intracranial local tumor control rate
研究概览
简要总结
Brain metastasis accounted for 10-15% of all breast cancer patients and even higher in patients with triple negative and HER2 overexpressed subtype. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, many studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. Also, several studies had demonstrated that 5-10 lesions had similar overall survival by using whole brain radiotherapy or stereotactic radiotherapy. Fractionated stereotactic radiotherapy(FSRT) is increasingly administered in the brain metastatic patients and retrospective studies had shown that FSRT had better local control and lower brain radiation necrosis than single fraction stereotactic radiation. Therefore, In this study, we explore to treat 1-10 brain metastasis lesion in breast cancer patients with FSRT.
详细描述
Breast cancer patients with 1-10 brain metastasis will be treated with FSRT for brain metastasis. 3 to 5 fractions and 8Gy per fraction will be used for these patients based on the lesion number and volume.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HER2 positive advanced breast cancer
- •Age>18 years.
- •1 to 10 brain metastases confirmed by enhanced brain MRI
- •Life expectancy of more than 12 weeks
- •Prior therapy of oral dexamethasone not exceeding 16mg/d
- •Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade
- •Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
- •Prior endocrine therapy were allowed
- •Anti-Her2 targeted treatment were allowed
- •Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
- •Time interval from chemotherapy was more than 2 weeks, endocrine therapy and anti-Her2 targeted treatment are allowed to be used concurrently with FSRT
- •Signed the informed consent form prior to patient entry
排除标准
- •Leptomeningeal or hemorrhagic metastases
- •Uncontrolled epilepsy
- •Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
- •Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
- •Inability to complete enhanced MRI
- •Patients who are difficult or unable to be followed-up
- •Not suitable for inclusion for specific reasons judged by sponsor
- •Patients who are receiving cytotoxic drug concomitantly
- •Have received prior radiotherapy for brain metastasis
研究组 & 干预措施
FSRT
3 to 5 fractions and 8Gy per fraction will be used for breast cancer patients with 1-10 brain metastases based on the lesion number and volume.
干预措施: Fractionated stereotactic radiotherapy(FSRT) (Radiation)
结局指标
主要结局
intracranial local tumor control rate
时间窗: 2 years
次要结局
- Adverse events(2 years)
- Intracranial Progression-Free Survival (PFS)(2 years)
- Intracranial distant metastasis rate(2 years)
- overall survival(OS)(3 years)