NCT00253448已完成2 期
Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Overall Survival After Treatment
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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme.
- Determine overall survival of patients treated with this regimen.
Secondary
- Determine 6-month progression-free survival of patients treated with this regimen.
- Determine the absence of tumor growth and/or activity on conventional MR/MR spectroscopy imaging in patients treated with this regimen.
- Determine the frequency and severity of RTOG (Radiation Therapy Oncology Group) CNS toxic effects in patients treated with this regimen.
- Determine the neurologic function and quality of life of patients treated with this regimen.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed grade IV malignant glioblastoma multiforme
- •Diagnosis by surgical biopsy or resection within the past 5 weeks
- •Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be performed prior to initiating study treatment
- •High-risk area of active tumor without margin by MR spectroscopy
- •Meets the following criteria for radiosurgery:
- •Maximum diameter ≤ 40 mm
- •Located > 5 mm from the optic nerve or chiasm
- •Does not involve the brainstem
- •No multifocal or recurrent malignant glioma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 50-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •At least 6 weeks since chemotherapy
- •Concurrent chemotherapy allowed
- •Endocrine therapy
- •Concurrent steroids allowed, but at the smallest therapeutic dose possible
- •Radiotherapy
- •No prior in-field radiotherapy to the head and neck
- •See Disease Characteristics
- •Recovered from prior surgery or any post-operative complication
- •Concurrent antiseizure medications allowed
排除标准
- 未提供
结局指标
主要结局
Overall Survival After Treatment
时间窗: Minimum of 5 years.
Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
次要结局
未报告次要终点
研究者
研究点 (4)
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