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
This is a multicenter, phase II, open-label study examining the effect of neoadjuvant lenvatinib being given to patients with extrathyroidal differentiated thyroid cancer (DTC) prior to surgery to remove cancerous tumors (thyroidectomy). \- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * This research study involves a study drug called lenvatinib. * It is anticipated that 30 people will participate in the study. The U.S. Food and Drug Administration (FDA) has not approved lenvatinib for the specific disease of extrathyroidal differentiated thyroid cancer (DTC) but it has been approved for other uses. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Orally
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Overall R0/R1 resection rate
Evaluate the overall R0/R1 resection rate, as defined by proportion of patients who undergo successful thyroidectomy with clear (R0) or microscopically positive surgical margins (R1).
Time frame: 112 Days
Resection rate of R0
Evaluate R0 resection rates in each of 4 pre-specified extrathyroidal anatomic target interfaces: R0=no cancer cells seen microscopically at the resection margin
Time frame: 112 Days
Resection rate of R1
Evaluate R1 resection rates in each of 4 pre-specified extrathyroidal anatomic target interfaces: R1 cancer cells present microscopically at the resection margin (microscopic positive margin)
Time frame: 112 Days
Change in Surgical complexity and morbidity score (SCMS)
The Thyroid Neck Group Morbidity Complexity Scoring and MGH/MEE-MSK-MD Anderson (MMM) Surgical Morbidity Complexity Score (SMCS) are incorporated, specifying on scale with 5 levels of complexity and morbidity of the surgery \[mild (level 0), moderate (level 1), severe (level 2), very severe (level 3), and unresectable (level 4)\]. The surgical morbidity/complexity scores will be collected at enrollment, prior to surgery, and based on intraoperative findings. The change in SCMS will be reported as the median SCMS value. Determined by structures requiring resection, the score takes into account preoperatively radiographically defined structures judged to be requiring resection with surgical complexity of the given resection/potential for complications, and expected patient morbidity/change of function from the resection.
Time frame: 112 Days
Primary surgery response rate
Evaluate the response rate (RR) prior to primary surgery based on Response Evaluation Criteria in Solid Tumors version 1.1
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Time frame: 112 Days
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
CTCAE version 5
Time frame: Up to 18 months
Unresectable to resectable conversion rate
The conversion rate will be summarized as frequency (%) \-- Determined by structures requiring resection, the RGS takes into account preoperatively radiographically defined structures judged to be requiring resection with surgical complexity of the given resection/potential for complications, and expected patient morbidity/change of function from the resection.
Time frame: 112 Days