Clinical trial NCT03565536: Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
Official title: Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer, Anaplastic
Keywords: Nexavar
Anaplastic Thyroid Cancer
Neoadjuvant Treatment
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thyroglobulin
timeFrame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
measure: CT assessment
timeFrame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
measure: Length of contact surface between tumor and common carotid artery
timeFrame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
measure: Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
timeFrame: 6 months after treatment with NEXAVAR
measure: MST
timeFrame: 12 months after treatment with NEXAVAR
Secondary outcomes:
measure: Overall tolerability of treatment as measured by rate of adverse events
timeFrame: 3 months after treatment with NEXAVAR
measure: ORR
timeFrame: 1 month, 2 months, 3 months after treatment with NEXAVAR
measure: TTP
timeFrame: 12 months after treatment with NEXAVAR
measure: Rate of III-IV grade adverse events
timeFrame: 12 months after treatment with NEXAVAR
Other outcomes:
Locations:
city: FuZhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: