Feasibility of a Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Single Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.
研究概览
简要总结
Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS is treatment consisting of highly focused radiation doses to the tumor. These two treatment modalities are both widely used, well established, and proven to improve survival, but so far, no study has been done to directly compare the efficacy of one over the other. Neither treatment in itself is considered to be experimental and both have been shown to provide benefits to patients with metastatic brain tumors. The aim of this study is to determine which two modalities are better for local control and improving quality of life.
Patients who consent to this study will be randomized to either receive surgery or Radiosurgery in the treatment of single brain metastases. The study seeks to recruit 12 patient to each group. Patients will be in this study for up to five years from the time of the treatment finished. This will include follow-up visits at 4 weeks after the procedure and then every 3 months after the procedure up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
- •Patients > 18 years
- •A contrast-enhanced MRI demonstrating the presence a single brain metastases <3cm performed within one month prior to registration
- •Life expectancy > 3 months
- •RPA Class 1 and RPA Class 2 patients with stable primary disease
- •Patients must have normal organ and marrow function
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •ECOG Performance Status 0-2
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Have tumor(s) in the midbrain, pons, or medulla, in eloquent cortex
- •Have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema
- •Be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses
- •Have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3)
- •Have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis
- •Significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol
- •Acute or untreated infections (viral, bacterial or fungal)
- •Be prisoners or other institutionalized individuals
- •Have a diagnosis of germ cell tumor, lymphoma or small cell lung cancer 10.Concurrent chemotherapy or molecularly targeted anti-cancer therapy
- •11.Allergy to Gadolinium 12.Imminent brain herniation, massive peritumoural oedema or hydrocephalus 13.Have any metallic implant that would exclude the possibility of having a brain MRI
结局指标
主要结局
To determine the feasibility of accrual to a randomized trial of SRS vs Surgery in patients with single brain metastasis.
时间窗: 2 years
To compare the incidence of recommendation for a second local therapeutic intervention to the treated metastasis at 1 year.
时间窗: 2 years
次要结局
- To compare overall survival between the two randomized cohorts.(2 years)
- To compare local-recurrence-free survival between the two randomized cohorts.(2 years)
- To compare CTCAE v 3.0 neurological outcomes(2 years)
- To evaluate difference in neurocognitive outcomes(2 years)
- To measure and compare quality of life(2 years)
- To determine adverse effects attributable to local therapy(2 years)
- To compare medication requirements in each cohorts (steroids, anticonvulsants)(2 years)
- To explore potential predictive factors of outcomes(2 years)
- To investigate potential biofluid and imaging biomarkers of response(2 years)
- To compare ECOG performance status(2 years)