Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer, Anaplastic
• Intervention / Treatment: Drug: Nexavar; Procedure: operation; Radiation: External radiation therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • FuZhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Nexavar neoadjuvant treatment group; 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; 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.; Other Names: Nexavar neoadjuvant treatment group; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: May 26, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Nexavar; Anaplastic Thyroid Cancer; Neoadjuvant Treatment
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Thyroid Carcinoma, Anaplastic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: UTC-NEXAVAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes