Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Thyroid Cancer, Anaplastic Clinical Trial

Official title:

Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565536
• Other study ID #: UTC-NEXAVAR
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2024
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer, Anaplastic
• Thyroid Carcinoma, Anaplastic
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Nexavar
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.

Procedure:
• operation
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.

Radiation:
• External radiation therapy
As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	FuZhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroglobulin	Thyroglobulin	Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Primary	CT assessment	Maximum tumor diameter measured by CT	Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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