NCT01017250已完成不适用
Radiosurgery and Avastin for Recurrent Malignant Gliomas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Central Nervous System (CNS) Toxicity
研究概览
简要总结
The purpose of this study is to assess the central nervous system (CNS) toxicity in patients with recurrent malignant gliomas treated with concurrent Avastin and stereotactic radiosurgery (SRS).
详细描述
In this pilot study, 15 human subjects with recurrent, unifocal malignant gliomas up to 5-cm in maximum dimension no longer responding to conventional chemotherapy but able to tolerate further chemotherapy will be enrolled. The primary endpoint of this study will be the proportion of patients who experience CNS toxicity, with secondary endpoints progression-free survival, overall survival, steroid dosage, development of radionecrosis, quality of life, objective radiographic response and performance status.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of malignant glioma (WHO Grade III or IV) of the brain treated with some combination of surgery, biochemotherapy and conventionally fractionated external beam radiotherapy
- •Radiotherapy completed at least 6 months prior to recurrence
- •Age 18 years and older
- •New or enlarging contrast-enhancing and/or 18FDG-avid nodule, at least 1 cm diameter
- •Estimated life expectancy of 3 months or longer
排除标准
- •Avastin therapy within 21 days of start of participation
- •Contraindication to Avastin therapy or brain MRI
- •Presence of bleeding diathesis or coagulopathy
- •History of prior arterial thrombotic event, myocardial infarction, angina, CVA, TIA, CABG angioplasty or stenting within 6 months.
- •Inadequately controlled hypertension (defined as systolic blood pressure
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •Clinically significant vascular disease
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to onset of treatment
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •History of abdominal fistula or GI perforation within 6 months prior to onset of treatment
- •Serious non-healing wound, active ulcer or untreated bone fracture
- •Proteinuria demonstrated by Urine Protein Creatinine ratio > 1.0
- •Pregnancy
研究组 & 干预措施
Stereotactic Radiosurgery
Experimental
Avastin and Radiosurgery
干预措施: Stereotactic Radiosurgery (SRS) (Radiation)
Stereotactic Radiosurgery
Experimental
Avastin and Radiosurgery
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Central Nervous System (CNS) Toxicity
时间窗: 2 months after Stereotactic Radiosurgery
Number of participants who experience Grade 3 or higher adverse events in the "Nervous System Disorder" domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
次要结局
- Progression-free Survival (PFS)(1 year)
- Overall Survival(OS)(2 years)
- Radiographic Response at Month 2(2 months after SRS)
- Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)(2 months after SRS)
- Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT)(2 months after SRS)
- Performance Status at 2 Months After Stereotactic Radiosurgery (SRS)(2 months after SRS)
- Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)(2 months after SRS)
- Steroid Usage After Stereotactic Radiosurgery (SRS)(2 months after SRS 2 months after SRS 2 months after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans(1 week after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans(2 months after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC(1 week after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC(2 months after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF(1 week after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF(2 months after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC(1 week after SRS)
- Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC(2 months after SRS)
研究者
研究点 (1)
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