NCT06558981招募中3 期
The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer：a 1:1 Randomized Phase III Clinical Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 124
- 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 clinical trial on the role of adjuvant radiotherapy in high-risk locally advanced differentiated thyroid cancer. Patients who meet the inclusion criteria were randomly assigned 1:1 to either the experimental group (adjuvant radiotherapy+RAI) or the control group (RAI), with LRFS as the primary endpoint of the study.
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
- •The patient voluntarily joined this study and signed an informed consent form;
- •Age: ≥ 14 years old,<80 years old, male or female not limited;
- •Histopathological diagnosis of differentiated thyroid cancer;
- •Surgical total or near total thyroidectomy;
- •The surgery did not achieve R0 resection, and R1/ R2 resection was performed. The volume of residual tumor in R2 resected patients is less than 2cm3;
- •The main organ functions are normal;
- •Good compliance and cooperation with follow-up.
排除标准
- •Previously received radiation therapy for the head and neck area;
- •Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
- •There is distant metastasis;
- •Previously received 131I treatment;
- •Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
- •Within 5 years or simultaneously suffering from other active malignant tumors. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group;
- •Pregnant or lactating women;
- •Other physical illnesses that affect patients' ability to receive standard treatment;
- •According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data;
- •Individuals with claustrophobia who are unable to undergo radiation therapy;
- •Patients deemed unsuitable for inclusion by other attending physicians.
结局指标
主要结局
Local-regional Recurrence Free Survival （LRFS）
时间窗: 5 years after surgery
The time from surgery to the occurrence of local-regional tumor recurrence based on the RECIST 1.1. The definition of local areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.
次要结局
- Adverse Events，AE(5 years after surgery)
- Overall Survival，OS(5 years after surgery)
- Quality of Life as assessed by QLQ-C30(5 years after surgery)
- Local-regional Recurrence Rate，LRR(5 years after surgery)
- Quality of Life as assessed by QLQ-H&N35(5 years after surgery)
- Progression Free Survival，PFS(5 years after surgery)
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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