Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Thyroglobulin
研究概览
简要总结
Undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. Most undifferentiated cancers lose the chance of surgery when they are first diagnosed. The current study, Nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. This study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.
详细描述
Undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. Most undifferentiated cancers lose the chance of surgery when they are first diagnosed. The current study, Nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. This study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.
We chose patients with recurrent or inoperable anaplastic thyroid cancer and used NEXAVAR for 1 month of neoadjuvant therapy. If tumor lesions begin to resolve, they continue neoadjuvant therapy until the end of the second month. The total duration of preoperative treatment is two months.at the end of the second month, a CT scan was performed to assess whether surgery could be performed. If surgery is possible, NEXAVAR will continue to perform adjuvant radiotherapy after the surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Undifferentiated or poorly differentiated thyroid cancer
- •Tumor invades the trachea, esophagus or common carotid artery that are Unresectable.
- •Locally recurrent anaplastic thyroid cancer
- •The lesion size is greater than 3cm
- •Patients in whom the oncologist has decide to start therapy with NEXAVAR.
排除标准
- •Lesions cannot be evaluated by imaging
- •Synonymous with contraindications to Nexavar.
研究组 & 干预措施
Nexavar neoadjuvant treatment group
After the patient had diagnosed as anaplastic thyroid cancer, Nexavar was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.
operation for possible surgical treatment,with complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.
then External radiation therapy after surgery.
干预措施: Nexavar (Drug)
Nexavar neoadjuvant treatment group
After the patient had diagnosed as anaplastic thyroid cancer, Nexavar was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.
operation for possible surgical treatment,with complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.
then External radiation therapy after surgery.
干预措施: operation (Procedure)
Nexavar neoadjuvant treatment group
After the patient had diagnosed as anaplastic thyroid cancer, Nexavar was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.
operation for possible surgical treatment,with complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.
then External radiation therapy after surgery.
干预措施: External radiation therapy (Radiation)
结局指标
主要结局
Thyroglobulin
时间窗: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Thyroglobulin
Length of contact surface between tumor and common carotid artery
时间窗: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Length of contact surface between tumor and common carotid artery
CT assessment
时间窗: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Maximum tumor diameter measured by CT
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
时间窗: 6 months after treatment with NEXAVAR
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
MST
时间窗: 12 months after treatment with NEXAVAR
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
次要结局
- ORR(1 month, 2 months, 3 months after treatment with NEXAVAR)
- TTP(12 months after treatment with NEXAVAR)
- Rate of III-IV grade adverse events(12 months after treatment with NEXAVAR)
- Overall tolerability of treatment as measured by rate of adverse events(3 months after treatment with NEXAVAR)
研究者
Bo Wang,MD
clinical professor
Fujian Medical University