Thyroid Cancer, AnaplasticPhase 2NCT03565536
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
A Phase 2 study testing Nexavar, operation and External radiation therapy in people with Thyroid Cancer, Anaplastic, run by Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Anaplastic
- What is being tested?
- Nexavar, operation and External radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 30 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lesions cannot be evaluated by imaging
- Synonymous with contraindications to Nexavar.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Cancer, Anaplastic
- Being tested
- Nexavar, operation, External radiation therapy
- Keywords
- Nexavar, Anaplastic Thyroid Cancer, Neoadjuvant Treatment
- Medical subject headings
- Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexavarDrug
Also called Nexavar neoadjuvant treatment group
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.
operationProcedure or surgery
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 therapyRadiation
As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nexavar; Procedure: operation; Radiation: External radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroglobulin
Thyroglobulin
Measured: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
CT assessment
Maximum tumor diameter measured by CT
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after treatment with NEXAVAR
Secondary outcomes (4)
Overall tolerability of treatment as measured by rate of adverse events
Overall tolerability of treatment as measured by rate of adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after treatment with NEXAVAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 May 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer, AnaplasticStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565536
- Sponsor's protocol ID
- UTC-NEXAVAR
- Status last verified
- Apr 2024
- First submitted
- 26 May 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03565536
- Acronym / sponsor ID
- UTC-NEXAVAR
- Conditions
- Thyroid Cancer, Anaplastic
- Keywords
- Nexavar, Anaplastic Thyroid Cancer, Neoadjuvant Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nexavar neoadjuvant treatment group | Experimental | Drug: Nexavar, Procedure: operation, Radiation: External radiation therapyAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Lesions cannot be evaluated by imaging
- Synonymous with contraindications to Nexavar.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexavarAlso: Nexavar neoadjuvant treatment groupfor 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. | Drug | Nexavar neoadjuvant treatment group |
| operationIf 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. | Procedure or surgery | Nexavar neoadjuvant treatment group |
| External radiation therapyAs the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy | Radiation | Nexavar neoadjuvant treatment group |
Primary outcome
Thyroglobulin
Time frame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR
Thyroglobulin
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
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
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
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
4 secondary outcomes
Overall tolerability of treatment as measured by rate of adverse events
Time frame: 3 months after treatment with NEXAVAR
ORR
Time frame: 1 month, 2 months, 3 months after treatment with NEXAVAR
TTP
Time frame: 12 months after treatment with NEXAVAR
Rate of III-IV grade adverse events
Time frame: 12 months after treatment with NEXAVAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexavar, operation and External radiation therapy in people with Thyroid Cancer, Anaplastic, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroglobulin (time frame: Change from Baseline Blood Thyroglobulin at 1 month, 2 months, 3 months after treatment with NEXAVAR). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.