A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility of Enrolling Patients
研究概览
简要总结
This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
- •Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
- •Patients must have no active brain metastasis >3cm in size.
- •Leptomeningeal disease is permitted
- •Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
- •Patients must have no symptoms attributable to active brain metastases.
- •At the time of enrollment, patients must be eligible for AND planning to begin a new line of systemic therapy with potential for CNS-efficacy. Determination of potential for CNS-efficacy will be determined based on the clinical judgement of the treating physicians. Patients must have had no prior exposure to the specific systemic therapy in question at the time of enrollment, though exposure to other medications from a similar class are acceptable at the discretion of the treating team.
- •Patient must be planning to defer radiation therapy to trial medical therapy regardless of enrollment on trial.
- •Must be age ≥ 18 years.
- •Patients must be willing to complete MoCA and FACT-BR assessments (refer to section 4.4.1).
- •Performance status: KPS performance status ≥50%.
- •Life expectancy of ≥3 months.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
- •Patients with active symptomatic brain metastases.
- •Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
- •Patients with conditions that exclude them from undergoing magnetic resonance imaging.
研究组 & 干预措施
SingleArm
CNS-Penetrating Systemic Therapy
结局指标
主要结局
Feasibility of Enrolling Patients
时间窗: 1 year
Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.
Feasibility of completing required surveillance imaging
时间窗: 1 year
Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.
Feasibility of administering Cognitive Assessments
时间窗: 1 year
Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
Feasibility of administering QOL Questionnaires
时间窗: 1 year
Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
次要结局
- Incidence of pre-defined safety events(1 year)
研究者
Aaron Benjamin Simon
Asst Prof
University of California, Irvine