Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node (Z0011-China)
A Prospective Randomized Multicenter Phase III Study of Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node--the Validation of Z0011 in China
The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node dissection (ALND) did not result in inferior survival. These patients, therefore, are unlikely to benefit from further surgery that results in a longer period of hospitalization, higher costs and higher postoperative morbidity. This result has been written in the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines.
However, Limitations of Z0011, such as failure to achieve target accrual and possible randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand, further testing in different country are needed.
The investigators design and begin a prospective randomized multicenter phase III study of ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.
研究概览
地位
条件
详细说明
OBJECTIVES:
To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.
OUTLINE: This is a randomized multicenter study. Before randomization, all women were stratified according to age (≤50 years, >50 years), tumor size(≤2cm, >2cm) and research center. All the patients underwent lumpectomy and sentinel lymph node biopsy (SLNB). Eligible women were randomly assigned to ALND or no ALND Active Comparator: Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes.
Experimental: No surgery of axillary lymph node in this arm. All the patients were to receive whole-breast opposing tangential-field radiation therapy. The use of adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Patients are followed up every 4 months for the first 2 years, every 6 months from the third year to the fifth year, and then annually for a total of 10 years.
研究类型
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Shandong
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Jinan、Shandong、中国、250117
- Shandong Cancer Hospital And Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Female;
- Patient aged 18 years and above;
- Patient with histological proven invasive breast cancer;
- Clinical T1-T2 disease with no distant metastasis;
- Patient with clinical N0 status;
- Patient for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic;
- Patient with positive SLNs 1~2;
- Signed consent to participate.
Exclusion Criteria:
- History of neoadjuvant chemotherapy or hormone therapy;
- History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
- History of any other invasive cancer;
- Initial metastatic disease known;
- Pregnant women or lactating women;
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Axillary Lymph Node Dissection
After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection.
Pathological evaluation (include intraoperative pathological examination) is performed routinely.
All women were to receive whole-breast opposing tangential-field radiation therapy.
Adjuvant systemic therapy was determined by the treating physician.
|
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
其他名称：
touch imprint cytology and/or frozen section and/or OSNA
Axillary lymph node dissection involving removal of at least level I and II nodes.
其他名称：
H&E and IHC
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
其他名称：
Whole-breast opposing tangential-field radiation therapy.
|
|
实验性的：Non-Axillary Lymph Node Dissection
After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial).
Pathological evaluation (include intraoperative pathological examination) is performed routinely.
All women were to receive whole-breast opposing tangential-field radiation therapy.
Adjuvant systemic therapy was determined by the treating physician.
|
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
其他名称：
touch imprint cytology and/or frozen section and/or OSNA
H&E and IHC
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
其他名称：
Whole-breast opposing tangential-field radiation therapy.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Disease Free Survival
大体时间：Time to relapse or progression up to 10 years
|
Time from randomization to relapse or death.
|
Time to relapse or progression up to 10 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：Time to death up to 10 years
|
Time from randomization to date of death.
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Time to death up to 10 years
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Axillary Recurrence Rate
大体时间：Time to local relapse up to 10 years
|
Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.
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Time to local relapse up to 10 years
|
合作者和调查者
调查人员
- 首席研究员：Jiong Wu, MD、Fudan University
- 首席研究员：Tao Ouyang, MD、Beijing Cancer Hospital and Institute
- 首席研究员：Feng-xi Su, MD、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- 首席研究员：Hong-yuan Li, MD、First Affiliated Hospital of Chongqing Medical University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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