Lenvatinib in Locally Advanced Invasive Thyroid Cancer
Lenvatinib in Locally Advanced Invasive Thyroid Cancer
Brief 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.
Detailed Description:
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
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arm:
- Experimental: LENVATINIB
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 30 |
| Estimated Study start date | 01 April 2020 |
| Estimated Study Completion Date | 23 July 2021 |