NCT02866981已完成2 期
Observation for Patients With Asymptomatic CNS Metastatic Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- CNS treatment-free survival rate
研究概览
简要总结
The purpose of this registry is to determine if select patients with CNS metastatic disease can be safely observed rather than treated. The investigators hypothesize that there is a subset of patients with small asymptomatic CNS mets that do not require treatment, these patients can simply be observed and will not have CNS progression.
详细描述
Subjects will be given a consultation with physician investigators in the department of one of the study investigators, who will introduce the study if the subject is potentially eligible.
Information collected at initial assessment:
- Quality of life survey (FACT-Br)
- History and Physical exam (to include KPS, disease status on most recent non-CNS imaging, chemotherapy history, age).
- Measurement of walking pace: patient will walk a pre- measured 6 meters, patient is to be instructed to walk at a normal pace. The time required to travel this distance will be recorded. For patients that are wheelchair bound or otherwise immobile, the pace will be recorded as '0'.
- Neurocognitive testing (Montreal Cognitive Assessment)
- MRI scan with contrast (must be within 6 weeks)
Observation and Follow-up Visits:
- Patients will be seen at 6 weeks and then every 2 months for follow-up (with physical exam) with repeat MRI with contrast at that time
- FACT-Br survey to be filled out at each follow-up
- Neurocognitive status (Montreal Cognitive Assessment)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CNS metastatic disease that meets the following:
- •No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration
- •No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration.
- •No previous treatment for the observed lesion. Patients may have had other lesions that have been treated as long as there is at least one index lesion that has not been treated. For example, patient may have had 3 lesions treated in March 2012 with radiosurgery and on recent scan is found to have a new 0.5 cm lesion, this patient is eligible.
- •Less than 5 untreated CNS lesions.
- •Able to have MRI scan with contrast
- •All CNS lesions are asymptomatic. Patient may have symptoms from previous treatment or cancer outside the CNS but cannot have symptoms attributable to the current CNS metastatic disease. This is left to the discretion of the treating physician and in some instances is not easy as sometimes CNS metastatic disease is incidental finding to un-related symptoms.
- •Eligible primaries
- •Lung (NSCLC)
- •Lung (SCLC) that have had previous Whole brain radiation
- •Head and Neck
排除标准
- •CNS lesion that does not meet following:
- •No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration
- •No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration.
- •More than 5 CNS lesions (can have had previously treated lesions by either surgery or radiation, but at time of protocol SRS must have 5 or less untreated lesions).
- •Symptomatic CNS lesions
- •Ineligible primaries
- •Primary CNS tumors
- •SCLC that has not had previous whole brain radiation
- •Leptomeningeal disease in CNS
- •Patients unable to have an MRI (secondary for example to metal hardware)
- •Patients unable to have MRI contrast (secondary for example to poor renal function
- •CNS lesion >0.8 cm in any dimension for patients not on targeted therapy with CNS penetration or >1.5 cm for patients on targeted therapy with CNS penetration.
- •Note that there is no KPS cut-off for eligibility
研究组 & 干预措施
Observation
Experimental
Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
干预措施: Observation (Other)
结局指标
主要结局
CNS treatment-free survival rate
时间窗: Every two months for two years
overall survival combined with CNS treatment
Overall survival
时间窗: Every two months for two years
Kaplan-Meier survival analyses
次要结局
- Neurocognitive testing(Every two months for two years)
- Indication for treatment(Every two months for two years)
- Quality of life(Every two months for two years)
- Natural History of untreated CNS met(Every two months for two years)
- Type of treatment(Every two months for two years)
研究者
研究点 (2)
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