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

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

Inclusion Criteria2

  • Patients with refractory iodine DTC treated with lenvatinib
  • Signed written informed consent

Exclusion Criteria1

  • \- Age \< 18 years

Interventions

DRUGLenvatinib

Patients will be treated by lenvatinib as recommended by good clinical practice


Locations(1)

Regina Elena National Cancer Institute

Rome, Italy

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NCT05789667


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