Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Measure the outcome of applying IGRT to PBI
研究概览
简要总结
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.
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. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).
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 65 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 or
- •patients older than 50 with serological evidence of post-menopausal status or
- •hysterectomized patients of any age with FSH confirmation of post-menopausal status
- •pT1 breast cancer, excised with negative margins
- •pN0 or sentinel node negative or N0 clinically if the tumor is < 1 cm in size
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)
结局指标
主要结局
Measure the outcome of applying IGRT to PBI
时间窗: 10 years
Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting. Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field
次要结局
- Feasibility of accelerated dose fractionation(1 - 10 years)
- Genetic pre-disposition of patient to post-treatment radiation fibrosis(1 - 10 years)