A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Rates of local control
研究概览
简要总结
This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.
详细描述
PRIMARY OBJECTIVES:
I. To assess the efficacy and safety of frameless fractionated stereotactic radiation therapy (FFSRT) on the treatment of solitary and oligometastatic brain metastases in the MD Anderson Houston Area Locations, MD Anderson Radiation Treatment Centers in New Mexico, MD Anderson affiliates and the main campus of MD Anderson, for patients unable or unwilling to undergo frame-based stereotactic radiosurgery (SRS).
SECONDARY OBJECTIVES:
I. To assess 6-month local control, intracranial progression-free survival and overall survival.
II. To collect data on charges and reimbursements of patients treated with FFSRT to compare those charges and reimbursements if the same patients had been treated with single-fraction, frame-based gamma knife SRS.
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
- 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
- •All patients with 1-4 metastatic brain lesions who are considered eligible for single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based SRS
- •One to 4 untreated metastatic brain lesions
- •Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal surgical candidate
- •Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning
- •Histologic confirmation of malignancy
- •For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
- •Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for imaging
- •No concurrent chemotherapy
- •Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection at the discretion of the treating physician however only new untreated lesions will be followed on protocol.
排除标准
- •Five or more metastatic brain lesions
- •Brain lesion(s) greater than 5 cm in diameter
- •Lesion(s) involving the brainstem, optic chiasm or optic nerve(s)
- •Patients unable to have IV contrast for computed tomography (CT) and MRI imaging
- •Patient unable to have an MRI of the brain
- •Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands
- •Positive pregnant status confirmed by serum or urine pregnancy test
- •Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS
- •Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
- •Prior whole brain radiotherapy or conventional external beam radiotherapy
结局指标
主要结局
Rates of local control
时间窗: Up to 1 year
Intracranial progression free survival (PFS)
时间窗: From enrollment to either the first observation of progression disease in the brain or death due to any cause, assessed up to 1 year
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial PFS.
Incidence of lesion failure based on imagining assessments for each lesion
时间窗: Up to 1 year
Overall survival (OS)
时间窗: Up to 1 year
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial OS.
Cost data
时间窗: Up to 1 year
Will be summarized using descriptive statistics such as mean, median, standard deviation, and range. Comparisons in cost between treatment modalities will be evaluated using a paired t-test where each patient will serve as his or her own control to determine if the cost of frameless fractionated stereotactic radiation therapy (FFSRT) is comparable to standard treatment.
次要结局
未报告次要终点