Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Conditions
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Thyroid Cancer, Anaplastic

Intervention / Treatment
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* Drug: Nexavar
* Procedure: operation
* Radiation: External radiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nexavar neoadjuvant treatment group<br>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. | Drug: Nexavar<br>* 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.<br>* Other names: Nexavar neoadjuvant treatment group;Procedure: operation<br>* 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.<br>Radiation: External radiation therapy<br>* As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroglobulin | Thyroglobulin | Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR | 
| CT assessment | Maximum tumor diameter measured by CT | 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 | 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 | 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 | 12 months after treatment with NEXAVAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall tolerability of treatment as measured by rate of adverse events | Overall tolerability of treatment as measured by rate of adverse events | 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 | 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 | 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 | 12 months after treatment with NEXAVAR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaplastic Thyroid Cancer, Neoadjuvant Treatment, Nexavar