Lenvatinib in Locally Advanced Invasive Thyroid Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04321954|
Recruitment Status : Not yet recruiting
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Differentiated Thyroid Cancer Advanced Cancer||Drug: LENVATINIB||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Neoadjuvant Lenvatinib in Locally Advanced Invasive Thyroid Cancer|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||November 23, 2020|
|Estimated Study Completion Date :||July 23, 2021|
Study procedures include screening for eligibility and study treatment, evaluations, and follow up visits
Other Name: Lenvima
- Overall R0/R1 resection rate [ Time Frame: 112 Days ]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).
- Resection rate of R0 [ Time Frame: 112 Days ]Evaluate R0 resection rates in each of 4 pre-specified extrathyroidal anatomic target interfaces: R0=no cancer cells seen microscopically at the resection margin
- Resection rate of R1 [ Time Frame: 112 Days ]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)
- Change in Surgical complexity and morbidity score (SCMS) [ Time Frame: 112 Days ]
The change in SCMS will be reported as the median SCMS value
-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.
- Primary surgery response rate [ Time Frame: 112 Days ]Evaluate the response rate (RR) prior to primary surgery based on Response Evaluation Criteria in Solid Tumors version 1.1
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0 [ Time Frame: Up to 18 months ]CTCAE version 5
- Unresectable to resectable conversion rate [ Time Frame: 112 Days ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321954
|Contact: Gregory Randolph, MD||617-573-4115||Gregory_Randolph@MEEI.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Contact: Gregory Randolph, MD 617-573-4115 Gregory_Randolph@MEEI.harvard.edu|
|Principal Investigator: Gregory Randolph, MD|
|Principal Investigator:||Gregory Randolph, MD||Massachusetts Eye and Ear Infirmary (MEEI)|