Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Assessment of acute and late toxicity
研究概览
简要总结
Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.
详细描述
The purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. Both immediate and long-term effects will be measured.
For patients with certain types of breast cancer, one standard treatment is removal of the area of cancer and a small amount of normal tissue around it followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". During this study, the single dose of electron irradiation (IOERT) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proven invasive breast carcinoma (ductal and lobular)
- •Age > 40 years
- •Karnofsky performance status >70%
- •Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci)
- •Nodal Status: NO-1
- •Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not required to achieve (-) margin.
- •All grades G1 - G3
- •Any hormonal receptor and Her-2 status
- •Informed consent
排除标准
- •In-situ Carcinoma without invasive component or multifocal disease > 4 cm
- •Tumor stage: T3 or 4
- •Nodal Status > N1 pathologically
- •Surgical margins < 2mm
- •Multicentricity
- •Previous radiotherapy to the involved breast
- •Karnofsky Index < 70%
- •Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus.
- •Distant metastases
- •Unable to provide written consent
结局指标
主要结局
Assessment of acute and late toxicity
时间窗: 5 years
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems: * At the end of Radiation Therapy * At time of first follow-up investigation (week 8 - 10) Assessment of late toxicity according to NSABP scoring - systems at 6, 12, 24, 36, 48, and 60 months
次要结局
- Cosmetic Evaluation(5 years)
- Overall Survival(5 Years)
- Disease Free Survival(5 years)