Sector Irradiation Versus Whole Brain Irradiation After Resection of Singular or Solitary Brain Metastasis - a Prospective Randomized Monocentric Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- local tumor control
研究概览
简要总结
Microneurosurgical resection of intracerebral metastases leads to prolonged survival and relief of symptoms in selected patients.
To minimize the risk of intracranial recurrence whole brain irradiation has been established as standard adjuvant treatment in those patients. Sector irradiation resembles a brain - tissue - sparing method by focusing the irradiation in the area of the tumor bed and a surrounding 1mm security margin.
The aim of this study is to investigate whether adjuvant "sector""-irradiation following microsurgical resection is equal to adjuvant whole brain irradiation in terms of local control and superior to in terms of quality of life and neurocognitive deficits in a prospective randomized trial.
详细描述
Microneurosurgical resection of intracerebral metastases leads to prolonged survival and relief of symptoms in selected patients. Traditionally whole-brain irradiation is the treatment of choice following surgical resection. Whole brain irradiation has been the standard approach to minimize the risk of intracranial recurrence following resection of brain metastases. Almost 2 decades ago, Patchell et al. established the superiority of resection of solitary metastases followed by whole brain irradiation compared with whole brain irradiation alone with regard to survival, local control, and length of functional independence. A following study by the same group failed to show a survival advantage for the addition of whole brain irradiation compared to surgical resection alone in patients with a solitary intracranial metastasis, although the likelihood of local and distant recurrence and death from neurological causes were significantly reduced by whole brain irradiation. Due to potential delayed neurocognitive effects associated with whole brain irradiation, investigators have evaluated the use of partial brain irradiation in the form of stereotactic radiosurgery instead of whole brain irradiation after resection of brain metastases. They showed that despite whole brain irradiation means superior control of brain recurrence in sites other than the resection bed, stereotactic radiosurgery after resection resulted in equivalent survival times and neurological preservation. In a retrospective series of 52 patients Karlovits et al. could show that stereotactic radiosurgery following surgical resection leads to equal local control compared to standard whole brain irradiation.
Study objective
The aim of this study is to investigate whether adjuvant "sector" -irradiation following microsurgical resection is equal to adjuvant whole brain irradiation in terms of local control and superior to in terms of quality of life and neurocognitive deficits in a prospective randomized trial.
Hypothesis
- Sector irradiation is equal to whole-brain irradiation in local tumor control after 3, 6, 12 and 36 months and
- Sector irradiation" is superior to whole-brain irradiation in terms of quality of life and neurocognitive function
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solitary/singular brain metastasis
- •Karnofsky Performance Index > 60%
- •Stable extracranial disease /CUP
- •Informed consent
排除标准
- •Small cell lung cancer
- •Squamous cell lung cancer
- •HER2-negative breast cancer
- •Deep-seated location (e.g. basal ganglia)
- •Expected surgery related neurological deficit
- •Tumor diameter < 3cm
结局指标
主要结局
local tumor control
时间窗: time from date of randomization until the date of first documented progression, assessed up to 36 months
次要结局
- local progression free survival(Time from randomization to the first documented tumor progressions in the resection cavity borders, assessed up to 36 months)
- overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
- distant brain metastasis(Time from date of randomization until the date of first documented progression elsewhere than the resection cavity, assessed at 3, 6, 12 and 36 months)
- time to clinical deterioration(Time from randomization to clinical deterioration, assessed by neurosurgeon in regular follow up visits at 3, 6, 12 and 36 months)
- neurocognitive functions(3, 6, 12 and 36 months postoperative)
- steroid dosage(3, 6, 12 and 36 months postoperative)
- quality of life(3, 6, 12 and 36 months)
研究者
Kerschbaumer Johannes
MD
Medical University Innsbruck