Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of recurrence in the breast
研究概览
简要总结
The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.
详细描述
Radiation therapy delivered to the whole breast is standard treatment following tumor removal for patients with early stage breast cancer. In selected patients, delivering the radiation treatment to only the part of the breast involved by the tumor may be a viable alternative. This can decrease the amount of normal tissues exposed to irradiation, potentially decrease side-effects and shorten the treatment time. Proton beam can decrease the volume of normal tissues treated compared to standard forms of radiotherapy. This study will recruit patients with early stage breast cancer following surgical removal to undergo partial breast radiotherapy with proton beam and determine the recurrence rates and side-effects of treatment.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast carcinoma
- •Age 40 years or higher
- •Primary tumor 3 cm or less
- •Lumpectomy with clip placement
- •Axillary node sampling
- •Negative margins
排除标准
- •Distant metastasis
- •Multicentric disease
- •Prior radiation or chemotherapy
- •Active collagen vascular disease
- •Pregnant or lactating
- •BRCA mutation
- •Lymph nodes with more than microscopic tumor involvement
研究组 & 干预措施
Partial Breast Proton Therapy
Two weeks of daily proton therapy delivered to the lumpectomy site.
干预措施: Proton Beam Radiotherapy (Radiation)
结局指标
主要结局
Rate of recurrence in the breast
时间窗: 5 years
次要结局
- Side-effects related to treatment(5 years)
- Rate of breast recurrence of low versus intermediate risk patients(5 years)
- Disease Free Survival(5 years)