Whole Brain Radiotherapy vs. Stereotactic Radiosurgery for 4 - 10 Brain Metastases:a Phase III Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 14
- 主要终点
- Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS
研究概览
简要总结
Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients with 4 up to 10 BM.
详细描述
Dutch guideline advices stereotactic radiosurgery (SRS) for patients with 1 up to 3 brain metastases (BM) and whole brain radiotherapy (WBRT) for patients with 4 or more BM. The interim analysis from the QUARTZ study showed that WBRT did not provide benefit in quality of life nor survival over best supportive care. WBRT has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. A recently published study showed that SRS in patients with 5 up to 10 BM had a comparable survival to patients treated with 2 up to 4 BM. Many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. The potential advantages of SRS i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. Next logic step would be to compare WBRT with SRS alone in patients with 4-10 BM and evaluate whether SRS is superior to WBRT with regard to QOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Minimal 4 up to a maximum of 10 BM on diagnostic MRI scan
- •Max diameter of single GTV 2.5cm
- •Max cumulative GTV of 30cm3
- •Karnofsky performance status ≥ 70
- •Any solid primary tumour. Small cell lung carcinoma, germinoma, and lymphoma are excluded
- •Ability to provide written informed consent
排除标准
- •Contra-indication for MRI
- •Prior treatment for BM (i.e. surgery, SRS or WBRT)
- •Concurrent use of systemic therapy
- •Maximum cumulative GTV of more than 30cm3 on planning-MRI
- •More than 10 BM on planning-MRI
- •A brainstem metastasis with a PTV of more than 20 cm3
结局指标
主要结局
Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS
时间窗: Change in quality of life measured from baseline to 3 months after radiotherapy
Quality of life is measured by the EQ-5D-5L, a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
次要结局
- Overall survival steroid use (mg), toxicity including hair loss and fatigue.(1 year)
- Time that patient is functioning independently (Karnofsky ≥ 70)(Change in Karnofsky index from baseline to 3 months after radiotherapy)
- Steroid use(Change in steroid use from baseline to 3 months after radiotherapy)
- Degree of independence(Change in independence from baseline to 3 months after radiotherapy)
- Toxicity measured by hair loss and fatigue(Change in toxicity from baseline to 3 months after radiotherapy)