Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer
详细描述
Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor.
Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women (at least 2 years without menstrual period):
- •hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.
- •Original tumor non-palpable (mammographically detected).
- •Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
- •N0 or sentinel node negative or N0 clinically if the tumor is <1 cm in size.
- •Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
- •Prescribed antihormonal therapy as part of their management.
排除标准
- •Previous radiation therapy to the ipsilateral breast.
- •Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
- •Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
- •Women with a diagnosis of multifocal breast cancer.
研究组 & 干预措施
Radiation Therapy: 6 Gy/ fraction
All patients will be treated with 6 Gy /fraction delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.
干预措施: 6 Gy/ fraction (Radiation)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Up to 5 years
次要结局
- TGF-beta 1 determinations(From baseline to up to 4 weeks)
- Ultrasound for target localization(up to 4 weeks)