Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Proportion of patients with a favorable response to Sorafenib defined as ONE OR MORE of the following criteria: 1. Reinduction of RaI uptake by RaI scintigraphy. 2. Serum thyroglobulin levels. 3. RECIST criteria
研究概览
简要总结
The purpose of this study is to assess whether therapy with Sorafenib reinduces radioiodine uptake in thyroid carcinoma.
详细描述
Background of the study:
Therapy with radioiodine (RaI) is the only curative therapy in non-medullary thyroid carcinoma. RaI uptake is frequently lost in this disease. Therapy with tyrosine kinase inhibitors may restore the susceptibility to RaI.
Objective of the study:
To investigate whether therapy with the tyrosine kinase inhibitor Sorafenib will increase the accumulation of radioiodine (RaI) and decrease tumor progression in patients with recurrences or metastases of non-medullary thyroid carcinoma with absent or insufficient accumulation of RaI.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-medullary thyroid carcinoma
- •The patients must have undergone total thyroidectomy
- •Presence of metastases or inoperable recurrent disease, as proven by elevated serum thyroglobulin levels (Tg) in combination with radiological evidence for tumor
- •No or insufficient RaI uptake in tumor as proven by RaI scintigraphy, performed after prior RaI therapy
排除标准
- •Pregnancy
- •Other active malignancies
- •Active kidney, liver or pancreatic disease or dysfunction
- •Unstable angina pectoris or recent (<3 months) myocardial infarction.
- •Coagulopathy
研究组 & 干预措施
sorafenib
30 patients with non-radioiodine avid differentiated thyroid carcinoma
干预措施: Sorafenib (nexavar) (Drug)
结局指标
主要结局
Proportion of patients with a favorable response to Sorafenib defined as ONE OR MORE of the following criteria: 1. Reinduction of RaI uptake by RaI scintigraphy. 2. Serum thyroglobulin levels. 3. RECIST criteria
时间窗: 6 months
次要结局
未报告次要终点