NCT06524167招募中不适用
A Real-world Study of Adjuvant Radiotherapy in High Recurrence Risk Locally Advanced Thyroid Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- LRRFS
研究概览
简要总结
This study is a real-world study to observe the role of adjuvant radiotherapy in locally advanced recurrent high-risk thyroid cancer. The study included thyroid cancer that requires adjuvant radiotherapy to increase local control rate, excluding undifferentiated cancer. Local-regional recurrence free survival is the primary endpoint of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients voluntarily join this study and sign an informed consent form;
- •Age: ≥ 14 years old,<80 years old, male or female not limited;
- •Thyroid cancer diagnosed by histopathology, including differentiated thyroid cancer, medullary carcinoma, poorly differentiated carcinoma, etc;
- •High risk of local late recurrence, meeting any of the following criteria:
- •The surgery did not achieve R0 resection;
- •After neoadjuvant therapy;
- •Pathological types with poor prognosis, such as poorly differentiated cancer, CASTLE, etc;
- •Thyroid cancer with obvious extracapsular invasion, invading important structures such as the esophagus, trachea, and recurrent laryngeal nerve, requiring adjuvant radiotherapy;
- •For patients with distant metastasis, researchers need to determine the value of local treatment;
- •The main organ functions are normal;
- •Good compliance and cooperation with follow-up.
排除标准
- •Untreated thyroid cancer or thyroid cancer that has only undergone surgical biopsy;
- •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;
- •Previously received radiation therapy for the head and neck area;
- •Pregnant or lactating women;
- •There are other physical illnesses that affect patients' ability to receive standard treatment;
- •According to the researcher's judgment, there may be other factors that could force the subject to terminate the study midway, 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 subject's safety or the collection of trial data;
- •Individuals with claustrophobia who are unable to undergo radiation therapy;
- •Other patients deemed unsuitable for inclusion by the treating physician.
结局指标
主要结局
LRRFS
时间窗: 5 years
Local-regional Recurrence Free Survival
次要结局
- AE(5 years)
- PFS(5 years)
- OS(5 years)
- QoL(5 years)
- DCR(5 years)
研究者
Yu Wang
Chief of Head-neck surgery, Fudan University Shanghai Cancer Center
Fudan University
研究点 (1)
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