Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
概览
- 阶段
- 不适用
- 干预措施
- Proton Beam Radiotherapy
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Loma Linda University
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of recurrence in the breast
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
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.
研究者
入排标准
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
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)