NCT01414738已完成2 期
Phase II Trial of Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean Change in *Delayed* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R DR) Score
研究概览
简要总结
The investigators hypothesize that avoidance of the hippocampal region with WBRT (Whole-Brain Radiotherapy ) may delay or reduce the onset, frequency, and/or severity of NCF (neurocognitive function) decline, as measured with clinical neurocognitive tools.
详细描述
We propose to use conformal avoidance of the hippocampal region during whole brain radiotherapy to reduce the dose to the hippocampi, thereby putatively limiting the radiation-induced inflammation of the hippocampal region and subsequent alteration of the microenvironment of the neural progenitor cells
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy.. Direct biopsy of CNS (central nervous system) lesions is not necessarily required although could constitute an allowed site of tissue confirmation as medically prudent. Patients who have been disease free for more than 5 years prior to the appearance of CNS metastases should undergo repeat biopsy of either a systemic metastasis or the CNS metastases to confirm the recurrent malignancy.
- •Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
- •Patients with measurable brain metastasis who have not been or will not be treated with SRS (stereotactic radiosurgery ) or surgical resection (Note: These treatment options are only permitted at relapse)
- •History/physical examination within 28 days prior to registration
- •Patients must fall into RTOG (Radiation Therapy Oncology Group) recursive partitioning analysis (RPA) class I or II
- •Patients must have a life expectancy of at least 4 months.
- •Age ≥ 18 years
- •Karnofsky performance status ≥ 70
- •Patients must provide study-specific informed consent prior to study entry
- •Women of childbearing potential and male participants must practice adequate contraception
- •Women of childbearing potential must have a negative, qualitative serum pregnancy test ≤2 weeks prior to study entry
排除标准
- •Patients with greater than 9 discrete metastases on MRI.
- •Patients with leptomeningeal metastases
- •Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
- •Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
- •Contraindication to MR (Magnetic resonance) imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
- •Serum creatinine > 1.4 mg/dl ≤ 28 days prior to study entry
- •Prior radiation therapy to the brain
- •Patients planning to undergo radiosurgery to any CNS lesion OR patients planning to have surgical resection of ALL of their CNS lesions
结局指标
主要结局
Mean Change in *Delayed* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R DR) Score
时间窗: Baseline, 3 months
The HVLT-R is a validated test to assess neurocognitive function and it incorporates 6 different forms, each including 12 nouns (targets) with 4 words drawn from 3 semantic categories. \*Delayed\*recall was measured by recalling the 12 targets after a 20-minute delay. 1 point is awarded for each successfully recalled target. There is no range- recalling more is more memory. Mean change was calculated by the following formula: 100\*(3 month - baseline) / baseline
次要结局
- Cumulative Incidence of Local Failure(1 year)
- Median Progression Free Survival(39 months)
- Mean Change in *Delayed Recognition* Score by Hopkins Verbal Learning Test-Revised (HVLT-R)(Baseline, 3 months)
- Mean Change in Neurocognitive Function as Measured by Controlled Word Association Test(Baseline, at 3 months)
- Mean Change in Trail Making Test (TMT- A) Score(Baseline, at 3 months)
- Mean Change in Cognitive Function as Measured by Medical Outcomes Scale (MOS)(Baseline, at 3 months)
- Mean Change in Cognitive Function as Measured by Mini-Mental Status Examination (MMSE)(Baseline, at 3 months)
- Median Overall Survival.(39 months)
- Mean Change in Relative Fatigue as Measured by Multidimensional Fatigue Inventory (MFI-20) Scores(Baseline, 3 months)
- Percentage of Participants With Local Failures Within the Region of Brain Within the CTV Receiving 20 Gy(1 year)
- Number of Adverse Events Grade 3 or Higher Based on CTCAE (Common Terminology Criteria for Adverse Events) Criteria.(From start of treatment up to 39 months)
- Mean Change in *Immediate* Recall Score by Hopkins Verbal Learning Test-Revised (HVLT-R)(Baseline, at 3 months)
- Mean Change in Trail Making Test (TMT- B) Score(Baseline, at 3 months)
- Cumulative Incidence of Intracranial Failure(1 year)
- Health-related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy With Brain Subscale (FACT-BR)(39 months)
- Number of Participants With Recurrence in the Hippocampus(5 months)
- Health-related Quality of Life as Assessed by Euroqol EQ-5D(39 months)
研究者
Robert Timmerman
PROFESSOR
University of Texas Southwestern Medical Center
研究点 (2)
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