A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.
详细描述
Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: no limit
- •Karnofsky performance status (KPS) ≥ 70
- •No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).
- •The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.
- •Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.
- •Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.
- •Informed consent must be obtained.
- •Pregnancy test must be negative for women of child bearing potential
排除标准
- •Inability of patient to be followed longitudinally as specified by protocol.
- •Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.
- •Women who are pregnant or nursing.
- •Failure to meet requirements in Inclusion Criteria
- •Contraindications to radiation.
研究组 & 干预措施
Hypofractionated Stereotactic Body Radiation Therapy
Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.
干预措施: Hypofractionated Stereotactic Body Radiation Therapy (Procedure)
Hypofractionated Stereotactic Body Radiation Therapy
Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.
干预措施: Hypofractionated Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Overall Survival
时间窗: 6 years
The percent of patients that survived from date of enrollment until 6 year follow-up visit
次要结局
- Percent of Patients With Lesion Local Control(6 years)
- Number of Participants Who Experienced a Grade 4 or 5 Toxicity(6 years)
研究者
Hong Zhang
Assistant Professor Department of Radiation Oncology
University of Rochester