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NCT Number: NCT03565536

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.

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Key information

Conditions

Thyroid Cancer, Anaplastic Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Thyroid Carcinoma, Anaplastic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

External radiation therapy

Radiation

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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