Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
Primary Purpose
Thyroid Cancer, Anaplastic
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nexavar
operation
External radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer, Anaplastic focused on measuring Nexavar, Anaplastic Thyroid Cancer, Neoadjuvant Treatment
Eligibility 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.
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nexavar neoadjuvant treatment group
Arm Description
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.
Outcomes
Primary Outcome Measures
Thyroglobulin
Thyroglobulin
CT assessment
Maximum tumor diameter measured by CT
Length of contact surface between tumor and common carotid artery
Length of contact surface between tumor and common carotid artery
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
MST
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
Overall tolerability of treatment as measured by rate of adverse events
Overall tolerability of treatment as measured by rate of adverse events
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
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
Rate of III-IV grade adverse events
Adverse events was evaluated during received protocol therapy according to CTCAE 4.03
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03565536
Brief Title
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
Official Title
Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Anaplastic
Keywords
Nexavar, Anaplastic Thyroid Cancer, Neoadjuvant Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nexavar neoadjuvant treatment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nexavar
Other Intervention Name(s)
Nexavar neoadjuvant treatment group
Intervention Description
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
Procedure
Intervention Name(s)
operation
Intervention Description
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
Radiation
Intervention Name(s)
External radiation therapy
Intervention Description
As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy
Primary Outcome Measure Information:
Title
Thyroglobulin
Description
Thyroglobulin
Time Frame
Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Title
CT assessment
Description
Maximum tumor diameter measured by CT
Time Frame
Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Title
Length of contact surface between tumor and common carotid artery
Description
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
Title
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Description
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Time Frame
6 months after treatment with NEXAVAR
Title
MST
Description
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
Time Frame
12 months after treatment with NEXAVAR
Secondary Outcome Measure Information:
Title
Overall tolerability of treatment as measured by rate of adverse events
Description
Overall tolerability of treatment as measured by rate of adverse events
Time Frame
3 months after treatment with NEXAVAR
Title
ORR
Description
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
Time Frame
1 month, 2 months, 3 months after treatment with NEXAVAR
Title
TTP
Description
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
Time Frame
12 months after treatment with NEXAVAR
Title
Rate of III-IV grade adverse events
Description
Adverse events was evaluated during received protocol therapy according to CTCAE 4.03
Time Frame
12 months after treatment with NEXAVAR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
FuZhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
We'll reach out to this number within 24 hrs