Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

NCT03565536 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: UTC-NEXAVAR
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer, Anaplastic

Keywords

Nexavar; Anaplastic Thyroid Cancer; Neoadjuvant Treatment

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Overall tolerability of treatment as measured by rate of adverse events

  3 months after treatment with NEXAVAR

• ORR

  1 month, 2 months, 3 months after treatment with NEXAVAR

• TTP

  12 months after treatment with NEXAVAR

• Rate of III-IV grade adverse events

  12 months after treatment with NEXAVAR

Study Arms (1)

Nexavar neoadjuvant treatment group

EXPERIMENTAL

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; Procedure: operation; Radiation: External radiation therapy

Interventions

Nexavar DRUG

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.

Also known as: Nexavar neoadjuvant treatment group

Nexavar neoadjuvant treatment group

operation PROCEDURE

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.

Nexavar neoadjuvant treatment group

External radiation therapy RADIATION

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

Nexavar neoadjuvant treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Lesions cannot be evaluated by imaging
• Synonymous with contraindications to Nexavar.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Interventions

Sorafenib; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 21, 2018
• Study Start: May 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)