Shandong Cancer Hospital Affiliated to Shandong University
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Degree of acute skin toxicity
研究概览
简要总结
In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients has had breast conserving surgery
- •age ≥ 18 and ≤ 65 years
- •with a histological diagnosis of invasive carcinoma of the breast
- •with pathological stage of T1-2N0-1M0
- •multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
- •informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •patients treated with Mastectomy
- •Need for lymph node irradiation
- •positive or close(≤ 1 mm) surgical margin
- •treated with neoadjuvant chemotherapy before surgery
- •Bilateral malignancy of the breast (synchronous or metachronous)
- •Pregnant or breastfeeding
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
结局指标
主要结局
Degree of acute skin toxicity
时间窗: 2 Weeks after the end of radiotherapy.
To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost
次要结局
- local control(From data of randomization until 60 months after the end of radiotherapy of last patients)
- Degree of chronic skin toxicity and cosmesis after radiotherapy(5 years after radiotherapy)
- overall survival(From date of randomization until 60 months after the end of radiotherapy of last patients)
研究者
Min Xu
Principal Investigator
Shandong Cancer Hospital and Institute