NCT04240548Unknown3 期
Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy
National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )
研究概览
简要总结
This is a phase III randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy
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
- •WHO performance status 0-1
- •Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis
- •Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan
- •Pathologic confirmation using, FNAC, core biopsy or excisional biopsy
- •ER, PR, Her2 neu and Ki67 status should be available for all patients
- •All patients should have received standard preoperative chemotherapy prior to surgery
- •At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla
- •Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization
排除标准
- •Poor performance status
- •Definitive clinical or radiologic evidence of metastatic disease
- •T4 tumors including inflammatory breast cancer
- •N3 disease detected clinically or by imaging
- •Patients with histologically positive axillary nodes after preoperative chemotherapy
- •Positive surgical margin after definitive surgery
- •Previous ipsilateral or contralateral breast cancer
- •Previous chest wall or breast irradiation
- •Second primary cancer
- •Active connective tissue disease
结局指标
主要结局
Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )
时间窗: time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years
axillary, internal mammary or supraclavicular recurrences
次要结局
- Disease Free survival(Time from randomization until local, regional or distant recurrence, assessed up to 10 years)
- Overall Survival(from randomization till death from any cause, assessed up to 10 years)
- Local Failure(from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years)
研究者
Rimoun Ramsis Anis Boutrus
Lecturer of Radiation Oncology
National Cancer Institute, Egypt
研究点 (2)
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