Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
To observe the quality of life (QOL) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (LAT) i.e. stereotactic radiotherapy (SRT) for patients with multiple (4-10) brain metastases
详细描述
Phase IV prospective non-randomized observational trial (registry trial) for patients with a DS-GPA > 1.5 or an estimated life expectancy of >3 months and an established diagnosis on dedicated brain MRI of 4-10 BM of any solid primary tumor.
We plan to deliver a local ablative therapy (LAT) i.e. SRT in 1 to 5 fractions on visible BM and post-surgical cavities if applicable.
Our primary aim is to provide quality of life (QOL) data and our secondary aim is to report on several toxicity and outcome parameters for this patient cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female, ≥ 18 years of age
- •Minimal 4 and up to a maximum of 10 synchronous BM diagnosed on a high resolution contrast-enhanced MRI scan (T1 gadolinium) not dated more than 4 weeks prior to inclusion.
- •Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm
- •Maximal cumulative GTV (+CTV for cavity) of 30cm3
- •Karnofsky performance status ≥ 70
- •DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or >3 months respectively.
- •Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded.
- •Ability to provide written informed consent and to participate in the procedure of the questionnaires.
排除标准
- •BM not amenable to SRT
- •Previous SRT or surgery on the same lesion
- •Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT
- •Any psychological, sociological or geographical issue potentially hampering compliance with the study
- •Concurrent use of systemic therapy
- •More than 10 BM on planning-MRI
- •Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI
- •A brainstem metastasis with a PTV of more than 20 cm3
- •Leptomeningeal disease
结局指标
主要结局
Quality of life
时间窗: From baseline to 3 month after radiotherapy
Measured by the PRO-CTCAE
次要结局
- Local control(Time from SRT until local progression or death whichever comes first, up to 3 years after LAT)
- Radiotherapy induced toxicity(Change in toxicity measured from baseline up to 3 years after radiotherapy)
- Quality of life(From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy)
- Survival(Time from SRT until death from any cause)