Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Failure-free survival
研究概览
简要总结
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.
详细描述
Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.
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
- •Patients with surgically removed histologically proven metastatic cancer
- •Subtotal or total resection of single brain metastasis
- •Presence of single brain metastasis in MRI
- •Karnofsky Performance Status ≥ 70
- •Life expectancy > 6 months (minimal extracranial disease or availability of effective oncology treatment)
- •No previous history of cranial irradiation
- •Availability of MRI
- •Starting radiotherapy within six weeks after neurosurgery
- •Negative pregnancy test for woman
- •Written informed consent
排除标准
- •Dementia and central nervous system diseases leading to higher risk of radiation toxicity
- •Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
- •Altered level of consciousness
- •Histologically proven metastatic small cell lung cancer
研究组 & 干预措施
SBRT to resection cavity
18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter
干预措施: stereotactic body radiotherapy (SBRT) (Radiation)
WBRT
30Gy in 10 fractions over 12 days to whole brain
干预措施: Whole-Brain Radiotherapy (WBRT) (Radiation)
结局指标
主要结局
Failure-free survival
时间窗: 5 months after radiotherapy
Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.
次要结局
- Overall survival(2 years)
- Quality of life assessment(2 years)
- Time to distant intracranial progression(2 years)
- Time to local progression(2 years)