Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Fujian Medical University

Status and phase: Completed; Phase 2

Conditions: Thyroid Cancer, Anaplastic

Treatments: Drug: Nexavar; Radiation: External radiation therapy; Procedure: operation

Study type: Interventional

Funder types: Other

Identifiers

NCT03565536

UTC-NEXAVAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Nexavar neoadjuvant treatment group

Experimental group

Description:

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.

Treatment:

Radiation: External radiation therapy

Procedure: operation

Drug: Nexavar