Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Recurrence Rate at the Surgical Site as Measured by MRI
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
详细描述
OBJECTIVES:
Primary
- To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).
Secondary
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone.
- To estimate the rate of new brain metastases outside of the adjuvant SRS site.
- To estimate patient quality of life after adjuvant SRS alone.
- To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients.
- To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients.
- To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease.
- To estimate the overall survival of these patients.
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
- •Age >18 years of age.
- •Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
- •Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or
- •Life expectancy of at least 3 months.
排除标准
- •Radiographic or cytologic evidence of leptomeningeal disease.
- •Patient with incomplete or partial resection.
- •Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
- •Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan.
- •Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
- •Pregnant or need to breast feed during the study period.
- •Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
- •Brain surgery other than for resection of metastasis.
- •Previous brain radiotherapy.
- •Contraindication to SRS, WBRT, or MRI.
研究组 & 干预措施
Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
干预措施: MMSE (Behavioral)
Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
干预措施: QOL via FACT-Br (Behavioral)
Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
干预措施: MRI (Procedure)
Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
干预措施: Post-operative SRS (Radiation)
结局指标
主要结局
Recurrence Rate at the Surgical Site as Measured by MRI
时间窗: 12 months
The number of months for local recurrence via MRI
次要结局
- Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam(Every 3 months for 12 months.)
- Quality of Life as Measured by the FACT-Br Subscales(Every 3 months for 12 months)
- Overall Survival(12 months)
- Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery(12 months)
- Rate of New Brain Metastases Outside of the Adjuvant SRS Site(12 months)
- Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)(12 months)
- Rate of Death Due to Neurologic Causes(12 months)