Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy Vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors
OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function.
II. Examine survival, clinical outcome, and local tumor imaging response in these patients.
研究概览
详细说明
PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution.
Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment.
The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first.
Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.
研究类型
注册
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
- Multiple newly diagnosed brain tumors
- Histologic confirmation of carcinoma at primary or metastatic site
- Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm
- No more than 4 tumors on magnetic resonance imaging
- Systemic disease controlled
- Neurologic function preserved
- Radiographic staging within 2 months of randomization required
- Performance status: Karnofsky 70%-100%
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
合作者和调查者
调查人员
- 学习椅：Douglas Kondziolka、University of Pittsburgh
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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