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Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT03565536
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Bo Wang,MD, Fujian Medical University

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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer, Anaplastic Drug: Nexavar Procedure: operation Radiation: External radiation therapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : October 30, 2019


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 Name: 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




Primary Outcome Measures :
  1. Thyroglobulin [ Time Frame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR ]
    Thyroglobulin

  2. CT assessment [ Time Frame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR ]
    Maximum tumor diameter measured by CT

  3. Length of contact surface between tumor and common carotid artery [ Time Frame: 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

  4. Percentage of patients in whom the actual dose of sorafenib equaled the planned dose [ Time Frame: 6 months after treatment with NEXAVAR ]
    Percentage of patients in whom the actual dose of sorafenib equaled the planned dose

  5. MST [ Time Frame: 12 months after treatment with NEXAVAR ]
    Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause


Secondary Outcome Measures :
  1. Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 3 months after treatment with NEXAVAR ]
    Overall tolerability of treatment as measured by rate of adverse events

  2. ORR [ Time Frame: 1 month, 2 months, 3 months after treatment with NEXAVAR ]
    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

  3. TTP [ Time Frame: 12 months after treatment with NEXAVAR ]
    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

  4. Rate of III-IV grade adverse events [ Time Frame: 12 months after treatment with NEXAVAR ]
    Adverse events was evaluated during received protocol therapy according to CTCAE 4.03



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565536


Locations
China, Fujian
Fujian Medical University Union Hospital Recruiting
FuZhou, Fujian, China, 350001
Contact: bo wang, md    13705947900    wangbo@fjmu.edu.cn   
Sponsors and Collaborators
Fujian Medical University

Responsible Party: Bo Wang,MD, clinical professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03565536     History of Changes
Other Study ID Numbers: UTC-NEXAVAR
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Bo Wang,MD, Fujian Medical University:
Nexavar
Anaplastic Thyroid Cancer
Neoadjuvant Treatment

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs