Thyroid Cancer, Anaplastic
Conditions
Keywords
Nexavar, Anaplastic Thyroid Cancer, Neoadjuvant Treatment
Brief summary
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.
Detailed description
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.
Interventions
DRUGNexavar
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.
PROCEDUREoperation
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.
RADIATIONExternal radiation therapy
As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy
Sponsors
Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Lesions cannot be evaluated by imaging * Synonymous with contraindications to Nexavar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MST | 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 |
| Thyroglobulin | Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR | Thyroglobulin |
| CT assessment | Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR | Maximum tumor diameter measured by CT |
| Length of contact surface between tumor and common carotid artery | 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 |
| Percentage of patients in whom the actual dose of sorafenib equaled the planned dose | 6 months after treatment with NEXAVAR | Percentage of patients in whom the actual dose of sorafenib equaled the planned dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 1 month, 2 months, 3 months after treatment with NEXAVAR | 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 |
| TTP | 12 months after treatment with NEXAVAR | 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 |
| Rate of III-IV grade adverse events | 12 months after treatment with NEXAVAR | Adverse events was evaluated during received protocol therapy according to CTCAE 4.03 |
| Overall tolerability of treatment as measured by rate of adverse events | 3 months after treatment with NEXAVAR | Overall tolerability of treatment as measured by rate of adverse events |
Countries
China
Outcome results
None listed