A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number o participants with Grade 2 or more toxicity
研究概览
简要总结
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
详细描述
This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Life Expectation: > 5 years
- •Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
- •Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
- •Unifocal tumour (confirmed by diagnostic MRI)
- •No lymphovascular invasion
- •ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
- •Negative radial resection margins of >= 2 mm
- •Surgical clips placed in the tumor bed
- •Written informed consent.
排除标准
- •Stage Ⅱ-Ⅲ
- •Multifocal tumors
- •Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma
- •Paget's disease of the nipple
- •Underwent oncoplastic surgery of ipsilateral breast
- •Underwent neoadjuvant chemotherapy or hormonal therapy
- •Previous or simultaneous contralateral breast cancer
- •Undergone ipsilateral chest wall radiotherapy
- •Active collagen vascular disease.
研究组 & 干预措施
APBI
Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks.
干预措施: APBI (Radiation)
WBI
Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks.
干预措施: WBI (Radiation)
结局指标
主要结局
Number o participants with Grade 2 or more toxicity
时间窗: 5 years
The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria: acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result
次要结局
- locoregional recurrence(5 years)
- disease-free survival(5 years)
- Quality of life measured with BR-23 questionnaire(2 years)
- distant-metastasis survival(5 years)
- overall survival(5 years)
研究者
Shulian Wang
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences