RecruitingNCT05789667

Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer

Observational Study on Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer

Sponsor

Regina Elena Cancer Institute

Enrollment

50 participants

Start Date

May 27, 2020

Study Type

OBSERVATIONAL

Conditions

Differentiated Thyroid Cancer Gender

Summary

Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a person's gender affects how well they respond to lenvatinib — a targeted therapy for thyroid cancer that has stopped responding to radioactive iodine treatment. By comparing outcomes between men and women, researchers hope to understand whether treatment should be tailored by gender. **You may be eligible if...** - You are 18 or older - You have differentiated thyroid cancer (DTC) that is refractory (no longer responding) to radioactive iodine treatment - You are being treated or have been treated with lenvatinib - You are willing to provide written informed consent **You may NOT be eligible if...** - You are younger than 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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