NCT06554652尚未招募3 期
Tracer Navigated Selective Neck Dissection Versus Modified Neck Dissection in Papillary Thyroid Cancer With Limited Lymph Node Metastasis in the Lateral Neck: A Randomized, Noninferiority Phase III Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Local-regional Recurrence Free Survival，LRFS
研究概览
简要总结
This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed PTC;
- •Age range: 14-80 years old;
- •Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
- •Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and <1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
- •Thyroid tumors without extra thyroidal extension;
- •Enough thyroid volume to inject tracer.
排除标准
- •Previous neck surgery;
- •Bilateral neck lymph node dissection;
- •Distant metastases;
- •High risk pathological subtypes or the presence of other high-risk factors for recurrence;
- •Previous treatment for thyroid cancer other than endocrine therapy;
- •The patient is unable to cooperate with follow-up.
结局指标
主要结局
Local-regional Recurrence Free Survival，LRFS
时间窗: 5 years
The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.
次要结局
- Progression Free Survival，PFS(5 years)
- Adverse Events，AE(5 years)
- Local-regional Recurrence Rate，LRR(5 years)
- Quality of Life as assessed by QoL/Thyroid(5 years)
- Overall Survival，OS(5 years)
- Quality of Life as assessed by UW-QOL V4.1(5 years)
研究者
Yu Wang
Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center
Fudan University
研究点 (1)
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