Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Change in Breast Cosmetic Outcome
研究概览
简要总结
A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.
详细描述
This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven breast cancer resected by lumpectomy
- •Female patient
- •Invasive breast cancer
- •Negative surgical margin
- •Age < or equal 50 years, or high-grade irrespective of age
- •Appropriate stage for protocol entry i.e. no metastasis
- •Performance Status 0-2
- •Hormone receptor status:
- •ER/PR Known
- •Borderline results are considered positive
排除标准
- •Metastatic patients
- •Paget's disease of nipple
- •Non-epithelial breast malignancy e.g. sarcoma, lymphoma
- •Unresected suspicious microcalcifications in the same or contralateral breast
- •Pregnant women
- •Inability to delineate lumpectomy cavity
- •Psychiatric or addictive disorders rendering treatment or follow-up difficult
结局指标
主要结局
Change in Breast Cosmetic Outcome
时间窗: 1 year
Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System
次要结局
- Acute Toxicity (Breast Skin)(During treatment and up to 3 months after treatment)
- Late Toxicity (Breast Skin, Heart, Lungs)(1 year)
- Patient Satisfaction: Breast Questionnaire (Breast Q)(1 year)
研究者
Rimoun Ramsis Anis Boutrus
Lecturer of Radiation Oncology
National Cancer Institute, Egypt