Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,052
- 试验地点
- 5
- 主要终点
- Loco-regional recurrence (LRR)
研究概览
简要总结
The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery
详细描述
Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group.
Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously.
Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially.
The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.
It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age18-70 years
- •Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy
- •Receive breast conserving surgery with negative margins
- •Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed.
- •The tumor bed is labeled with clips and it can be drawn on the treatment planning system.
- •Pathologically confirmed invasive breast cancer
- •Pathologically stage is T1-3N0-3M0
- •Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery
- •No distant metastases
- •No supraclavicular or internal mammary nodes metastases
- •No neoadjuvant chemotherapy
- •Fit for postoperative radiotherapy. No contraindications to radiotherapy
- •Signed informed consent
排除标准
- •T4 or M1 breast cancer
- •Supraclavicular or internal mammary nodes metastases
- •Pathologically confirmed DCIS only without an invasive component
- •Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
- •Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
- •Multiple lesions can not be removed by single quadrantectomy
- •Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
- •Patients with severe non-malignant comorbidity in cardiovascular or respiration system
- •Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
- •Previous radiotherapy to the chest wall or regional lymph node areas
- •Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
- •Pregnant or lactating
- •Conditions indicating that the patient cannot go through the radiation therapy or follow up
- •Unable or unwilling to sign informed consent
研究组 & 干预措施
Hypofractionated Radiotherapy
40 Gy/15 fractions irradiation is delivered to the whole breast, 2.67 Gy per fraction, 5 fractions weekly.
Tumor bed is boosted to 48 Gy simultaneously, 3.2 Gy per fraction, 5 fractions weekly.
干预措施: Hypofractionated Radiotherapy (Radiation)
Conventional Irradiation
50 Gy/25 fractions irradiation is delivered to the whole breast, 2 Gy per fraction, 5 fractions weekly.
Additional 10 Gy/5 fractions is boosted to tumor bed sequentially, 2 Gy per fraction, 5 fractions weekly.
干预措施: Conventional fractionated Radiotherapy (Radiation)
结局指标
主要结局
Loco-regional recurrence (LRR)
时间窗: 5 years
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes).
次要结局
- Overall survival (OS)(every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years)
- Number of patients with radiation-induced late toxicity assesses by CTCAE4.03(before treatment, every year after the last fraction received through 10 years)
- Quality of Life Score assessed by EORTC-QLQ-C30 (version 3)(before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years)
- Disease free survival (DFS)(every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years)
- Distant metastasis free survival (DMFS)(every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years)
- Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03(before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished)
- Harvard/NSABP/RTOG Breast Cosmesis Grades of patients(before treatment, every year after the last fraction received through 10 years)
- Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment(before treatment, every year after the last fraction received through 10 years)
- Quality of Life Score assessed by EORTC breast-cancer module (BR23)(before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years)
- Number and percentage of peripheral blood lymphocytes(before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation)
研究者
Xiaoli Yu
Associate Professor of department of radiation oncology
Fudan University