Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Ipsilateral Breast Tumor Recurrence-free Survival
研究概览
简要总结
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
详细描述
Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive ductal, medullary, papillary, colloid or tubular histologies
- •Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen.
- •No more then 3 positive nodes on axillary dissection or negative sentinel node.
- •Negative surgical margins (>2mm)
排除标准
- •Invasive lobular histology
- •Previous chemotherapy for breast cancer
- •Extensive intraductal component
- •Collagen vascular disease
- •Prior malignancy unless disease-free for 5 years
- •Patients who are pregnant or lactating
结局指标
主要结局
Ipsilateral Breast Tumor Recurrence-free Survival
时间窗: Up to 5 years post-treatment completion, average of 48 months
Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam
次要结局
- Overall Survival(Up to 5 years post- completion of treatment, average 48 months)
研究者
David Bush
Principal Inverstigator
Loma Linda University
