Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of stereotactic body radiotherapy (SBRT)
研究概览
简要总结
This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are:
- radio-biological advantage of a short highly effective treatment schedule
- possibility of preventing lesions to become symptomatic
- possibility of continuing systemic treatment without interruption
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years or older
- •Histologically confirmed diagnosis of invasive breast carcinoma (biological immunohistochemical profile: luminal and/or human epidermal growth factor receptor 2 positive)
- •Distant metastatic disease not progressing after 6 months of systemic therapy
- •Zubrod Performance status of 0-1
- •Unifocal tumour < 5 cm tumor size
- •Tumor CT or 18-labeled fluorodeoxyglucose positron emission tomography (5FDG-PET) detectable
- •No surgery being recommended at time of enrollment.
排除标准
- •prior radiotherapy
- •active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash
- •Women who are pregnant or lactating.
- •Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
结局指标
主要结局
Maximum tolerated dose of stereotactic body radiotherapy (SBRT)
时间窗: 6 months
the dose of radiotherapy associated with a ≤ 20% rate pre-specified treatment-related dose -limiting toxicity (DLT) occurring within 6 months from the start of treatment. DLT is defined as any grade 3 or worse toxicity according to CTCAE v.4 related to the following specific symptoms: * Radiation dermatitis grade \> 3 * Breast pain grade 3 * Breast infection grade \> 3 * Breast asymmetry grade 3 * Fibrosis grade \> 3 * Skin atrophy grade 3 * Rib fracture grade 3 * Chest wall pain grade 3
次要结局
- Rate of long-term adverse events(2 years)
- QoL(2 years)
- Breast Cosmesis(2 years)
- Primary breast tumor best response(2 years)