NCT04532177进行中（未招募）不适用
Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Partial and complete response rate by clinical and radiographic response
研究概览
简要总结
This is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (SBRT) as a treatment for breast cancer in patients who do not get surgery. The study will accrue 15 patients who will be treated to a dose of 40 Gy over the course of 5 fractions in the Stony Brook University Hospital Department of Radiation Oncology. The subjects will then have a follow up time of 5 years.
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
- •Age >/= 18
- •Biopsy proven invasive carcinoma of the breast
- •Clinical T1-T4 invasive carcinoma
- •Cancer is deemed unresectable with no possibility of future resection or the patient is a poor surgical candidate as determined following evaluation by a surgeon.
- •Women who are not post-menopausal should have a negative urine or serum pregnancy test. Women of childbearing potential must agree to adequate contraception for the duration of study participation.
- •Ability to understand and willingness to sign a written informed consent document
- •Life expectancy > 6 months
- •Patient is to be treated at Stony Brook University Hospital
排除标准
- •Women with a known pregnancy, positive serum pregnancy test, or currently breastfeeding as well as women of childbearing potential unwilling or unable to use an acceptable method of birth control (including abstinence or barrier method of birth control) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Breast implant in the breast to be treated with SBRT
- •Insufficient breast imaging to judge clinical stage
- •Inability to receive study treatment planning and treatment secondary to body habitus
- •Inability to understand or unwillingness to sign a written consent document
- •Life expectancy < 6 months
- •Children (< 18 years of age)
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with study requirements
结局指标
主要结局
Partial and complete response rate by clinical and radiographic response
时间窗: 5 years
Rates of acute and late adverse events grade 3 or greater
时间窗: 5 years
Rates of acute and late grade 3 or greater toxicity
次要结局
- Survival(5 years)
研究者
Alexander Stessin
Clinical Assistant Professor of Medicine
Stony Brook University
研究点 (2)
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