Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
- Conditions
- Thyroid Cancer, Anaplastic
- Interventions
- Registration Number
- NCT03565536
- Lead Sponsor
- Fujian Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- Lesions cannot be evaluated by imaging
- Synonymous with contraindications to Nexavar.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nexavar neoadjuvant treatment group Nexavar 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. Nexavar neoadjuvant treatment group External radiation therapy 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. Nexavar neoadjuvant treatment group operation 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.
- Primary Outcome Measures
Name Time Method Thyroglobulin 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 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 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 6 months after treatment with NEXAVAR Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳FuZhou, Fujian, China