Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response at 6 weeks as assessed by MRI and/or scan
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.
Secondary
- Evaluate the tolerability.
- Compare the duration of response.
- Compare local progression-free survival.
- Compare overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
干预措施: radiation therapy (Radiation)
Arm II
Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
干预措施: temozolomide (Drug)
Arm II
Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Response at 6 weeks as assessed by MRI and/or scan
次要结局
未报告次要终点