NCT00107367Unknown1 期
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Local control rate as measured by MRI with contrast at 1 year
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.
详细描述
OBJECTIVES:
Primary
- Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.
Secondary
- Determine the survival of patients treated with this therapy.
- Determine distant recurrence of disease in patients treated with this therapy.
- Determine the toxicity of this therapy in these patients.
- Determine the quality of life of patients treated with this therapy.
研究设计
- 研究类型
- Interventional
- 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:
- •Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan
- •Resectable disease
- •Histological evidence of metastatic carcinoma by intraoperative pathology
- •No primary lymphoma, germ cell carcinoma, or small cell lung cancer
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No uncontrolled hypertension
- •No unstable angina pectoris
- •No uncontrolled dysrhythmias
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No serious infection
- •No other medical illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery
- •No concurrent external beam radiotherapy to the brain
- •Not planning adjuvant whole brain radiotherapy after study therapy
- •Not specified
- •No other prior conventional or investigational local or systemic agents for brain metastasis
排除标准
- 未提供
结局指标
主要结局
Local control rate as measured by MRI with contrast at 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or PineoblastomaBrain and Central Nervous System TumorsLong-term Effects Secondary to Cancer Therapy in ChildrenNCT00105560Massachusetts General Hospital59
Unknown
1 期
Intensity-Modulated Radiation Therapy in Treating Patients With Prostate CancerProstate CancerNCT00946543Royal Marsden NHS Foundation Trust198
已完成
2 期
Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine MetastasisMetastatic CancerPainNCT00922974Radiation Therapy Oncology Group399
终止
1 期
Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck CancerHead and Neck CancerNCT00573989Wake Forest University Health Sciences27
已完成
1 期
Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate CancerProstate CancerNCT00482807University of Nebraska9