NCT07755423Enrolling By Invitation不适用
Stereotactic Body Radiotherapy for the Treatment of Distant Metastases in Thyroid Cancer: A Phase II Prospective Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Disease Control Rate，DCR
研究概览
简要总结
The goal of this observational study is to evaluate the efficacy and safety of Stereotactic Body Radiotherapy in the treatment of distant metastatic thyroid cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with primary lesion pathologically confirmed as thyroid cancer, and distant metastatic lesions confirmed either by pathology or by two types of imaging modalities. Based on the investigator's judgment, the participant's distant metastatic lesions are expected to be tolerable to Stereotactic Body Radiotherapy (SBRT). The distant metastases should be oligometastatic (total number of metastatic lesions ≤ 5).
- •Participants who have failed prior systemic therapy. Systemic therapy includes radioactive iodine therapy, immunotherapy, targeted therapy, clinical trial therapy, etc.
- •Age: 18 - 70 years old.
- •Expected survival period ≥ 3 months.
- •Before treatment, neutrophils ≥ 1.6 × 109/L, hemoglobin ≥ 80g/L, platelets ≥ 80×109/L; creatinine clearance rate ≥ 60 ml/min; non-hepatic metastasis patients (total bilirubin ≤ 1.5 times the upper limit of normal, ALT ≤ 1.5 times the upper limit of normal, AST ≤ 1.5 times the upper limit of normal), hepatic metastasis patients (total bilirubin ≤ 3 times the upper limit of normal, ALT ≤ 3 times the upper limit of normal, AST ≤ 3 times the upper limit of normal, normal coagulation function, Child-Pugh grade A or B, normal liver tissue volume > 700 mL)
- •Signed informed consent form and willing to complete the study according to the protocol.
排除标准
- •Patients who achieved complete remission after comprehensive treatment.
- •Pathologically confirmed as a second primary tumor.
- •Received radiotherapy to the corresponding area and the radiotherapy site overlapped with this one.
- •Uncontrollable malignant pleural or peritoneal effusion.
- •Severe internal medical complications and contraindications to radiotherapy.
- •Pregnant women of childbearing age with positive pregnancy test or lactating women.
- •Active mental disorders or other psychological disorders that affected the patient's signing of informed consent and understanding ability.
- •Uncontrollable infections or active infections, such as immunodeficiency or AIDS patients.
研究组 & 干预措施
treatment group
radiotherapy
干预措施: SBRT (Radiation)
结局指标
主要结局
Disease Control Rate，DCR
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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