Lenvatinib in Locally Advanced Invasive Thyroid Cancer (NCT04321954) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lenvatinib in Locally Advanced Invasive Thyroid Cancer
United States30 participantsStarted 2021-03-09
Plain-language summary
This research is being done to evaluate the safety and efficacy of neoadjuvant lenvatinib on surgical outcomes of patients with invasive extrathyroidal differentiated thyroid cancer (DTC).
This research study involves a study drug called lenvatinib
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years of age at the time of informed consent and willing and able to provide written informed consent for the trial.
* Adult participants who are either initially diagnosed with locally advanced thyroid neoplasm or have experienced persistent or recurrent thyroid and/or cervical nodal recurrent DTC (participants with M1 disease are allowed, AJCC 8th edition stage I-IVb)), including:
* a. Papillary thyroid carcinoma (PTC) - classical and variants
* Follicular variant
* Variants including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, HĂĽrthle cell variant of papillary carcinoma
* b. Follicular thyroid carcinoma (FTC)
* c. HĂĽrthle cell carcinoma
* d. Poorly differentiated thyroid carcinoma
* e. Cytologically confirmed thyroid neoplasm, Bethesda 3, 4 and 5
* Evidence of extrathyroidal extension and/or locally invasive disease and deemed at risk for R2 resection by treating team on clinical and/or fiberoptic examination and/or radiographic evaluation in the primary or recurrent setting. Evidence of "at risk for R2 resection" includes:
* a. Vocal cord paralysis by fiberoptic examination
* b. Extrathyroid and/or extranodal extension on CT or MRI, including tracheal and/or laryngeal cartilage invasion, esophageal involvement, and/or involvement of perithyroid muscles (e.g. strap, sternocleidomastoid, inferior constrictor muscles) o…