Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Grade 2 or 3 Fibrosis
研究概览
简要总结
The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days
详细描述
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator.
The women in this study will receive either 5 or 3 radiation fractions to the tumor bed. We have chosen to study T1 post menopausal women because in this subset: 1) the tumor is small enough to be treated by partial breast radiation 2) the odds of having multicentric disease are low, making it ethical to avoid whole breast irradiation, 3) the most benefit from reducing the radiation schedule from 5 to 3 could be expected.
All patients will receive either 8 Gy x 3 over 5 days, every other day or 6 Gy x 5 over 5 days, on five consecutive days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women defined as either:
- •at least 2 years without menstrual period
- •patients older than 50 with serological evidence of post-menopausal status
- •hysterectomized patients of any age with FSH confirmation of post- menopausal status
- •pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis:
- •Screen-detected
- •Low to intermediate nuclear grade
- •< 2.5cm in size
- •Resected with negative margins at >3mm)
- •clinically N0 or pN0 or sentinel node negative breast cancer
排除标准
- •previous radiation therapy to the ipsilateral breast
- •presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
研究组 & 干预措施
PBI Radiotherapy 6 Gy
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
干预措施: PBI Radiotherapy 6 Gy (Radiation)
PBI Radiotherapy 8 Gy
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
干预措施: PBI Radiotherapy 8 Gy (Radiation)
结局指标
主要结局
Percentage of Participants With Grade 2 or 3 Fibrosis
时间窗: 60 months
次要结局
- Rate of Isolated Local/Regional Recurrences(3 years post randomization)
- Rate of Concomitant Local/Regional and Distant Recurrences(3 years post randomization)
- Rate of Concomitant Local/Regional and Distant Recurrences(2 years post randomization)
- Rate of Isolated Local/Regional Recurrences(1 year post randomization)
- Rate of Isolated Local/Regional Recurrences(2 years post randomization)
- Rate of Concomitant Local/Regional and Distant Recurrences(1 year post randomization)