NCT06383663尚未招募不适用
A Prospective Multicenter Randomized Controlled Trial of the Prognostic Effects of Supraclavicular Lymph Node Dissection vs. No-dissection in Ipsilateral Supraclavicular Lymph Node Metastasis in Breast Cancer
Sun Yat-sen University0 个研究点目标入组 452 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 452
- 主要终点
- DFS
研究概览
简要总结
The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.
详细描述
In this study, patients with ipsilateral supraclavicular lymph node positive breast cancer were selected as research subjects. Randomized controlled method was used to study the effects of surgical dissection of supraclavicular lymph node combined with radiotherapy and radiotherapy alone on progression-free survival and overall survival of breast cancer. This RCT aims to explore the best treatment method for ipsilateral supraclavicular lymph node metastasis and to provide the basis for guiding the precise treatment of supraclavicular lymph node chain.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018;
- •Supraclavicular lymph node metastasis was confirmed by pathology;
- •Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
- •Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
- •Have at least one measurable target lesion according to RECIST criteria;
- •ECOG score ≦ 1;
- •The level of organ function must meet the following requirements: adequate bone marrow reserve: absolute counts of neutrophils (lobed and band neutrophils) ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. Liver: Bilirubin <1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 times the upper limit of normal. Renal: Creatinine clearance ≥ 45 mL/min;
- •No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
- •normal mind, can cooperate to complete the treatment;
- •Expected survival ≥36 months
- •In accordance with the requirements of the Ethics Committee, there is an informed consent signed by the patient or her legal representative, or an informed consent signed by the patient and her family.
排除标准
- •The range of metastasis exceeds the neck IV and VB region;
- •En-bloc resection cannot be achieved;
- •Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
- •Preoperative examination found distant metastasis;
- •Pregnant, lactating or inflammatory breast cancer patients;
- •Diseases associated with immune, endocrine or cardiovascular systems;
- •Previous history of other tumors or combined with other tumors;
- •Refusing to comply with the study protocol and refusing to sign the informed consent
结局指标
主要结局
DFS
时间窗: 5-year
Disease-free survival
次要结局
- OS(5-year)
- PFS(3-year)
研究者
Weidong Wei
Professor
Sun Yat-sen University
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