Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

NCT ID: NCT03565536

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Thyroid Cancer, Anaplastic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nexavar

Intervention Type 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.

operation

Intervention Type 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.

External radiation therapy

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

External radiation therapy

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

Intervention Type RADIATION

Other Intervention Names

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Nexavar neoadjuvant treatment group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Bo Wang,MD

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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UTC-NEXAVAR

Identifier Type: -

Identifier Source: org_study_id

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