Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
试验速览
- 阶段
- 不适用
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Axillary recurrence
研究概览
简要总结
This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.
详细描述
Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18~70 years old
- •Pathologically confirmed invasive breast cancer
- •A clinical T1-2N0M0 tumor
- •Treated with breast conserving surgery and sentinel lymph node biopsy
- •1~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases.
- •ECOG score 1~2
- •Written informed consent
排除标准
- •Patients underwent complete axillary lymph node dissection
- •Patients underwent mastectomy
- •Patients underwent neoadjuvant therapy
- •Clinically node positive pre-operative
- •Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- •Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years
- •Previous radiation therapy of breast or thorax
- •Medical contraindication for radiotherapy
- •Prior axillary surgery or radiotherapy
- •Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy
- •Pregnant or nursing
结局指标
主要结局
Axillary recurrence
时间窗: 5 years
次要结局
- Overall survival(5 years)
- Complications(baseline，1，2，3，4，5 years)
- Local-regional recurrence(5 years)
- Disease free survival(5 years)
研究者
Xiaoli Yu
Professor of department of radiation oncology
Fudan University