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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
for Unresectable tumors ,After the patient had diagnosed as anaplastic thyroid cancer, Nexavar 400mg Bid was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.
If computed tomography (CT) evaluates for possible surgical treatment, complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.
As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Thyroglobulin
Thyroglobulin
Time frame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
CT assessment
Maximum tumor diameter measured by CT
Time frame: 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
Length of contact surface between tumor and common carotid artery
Time frame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Time frame: 6 months after treatment with NEXAVAR
MST
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
Time frame: 12 months after treatment with NEXAVAR
Overall tolerability of treatment as measured by rate of adverse events
Overall tolerability of treatment as measured by rate of adverse events
Time frame: 3 months after treatment with NEXAVAR
ORR
Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after treatment with NEXAVAR
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Time frame: 1 month, 2 months, 3 months after treatment with NEXAVAR
TTP
Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death
Time frame: 12 months after treatment with NEXAVAR
Rate of III-IV grade adverse events
Adverse events was evaluated during received protocol therapy according to CTCAE 4.03
Time frame: 12 months after treatment with NEXAVAR