Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients with refractory iodine DTC treated with lenvatinib
Signed written informed consent
Disqualifiers
None
Trial population
Patients affected by radio-refractory iodine differentiated thyroid cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lenvatinib
DrugPatients will be treated by lenvatinib as recommended by good clinical practice
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Gender difference in Safety profile of lenvatinib treatment
Difference in lenvatinib dose reduction between male and female patients
Time frame
1 yearSecondary outcomes
1
Gender difference in lenvatinib side effects incidence
Difference in number of lenvatinib side effects between male and female patients according to CTCAE 5.0
Time frame
1 year2
Gender difference in lenvatinib response rate
Difference in lenvatinib response rate (CR+PR) according to RECIST response evaluation criteria 1.1 in male and female patients.
Time frame
1 year3
Gender difference progression free survival and overall survival of patients treated with lenvatinib
Difference in progression free survival and overall survival of patients treated with lenvatinib in male and female patients.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Regina Elena Cancer Institute
Lead sponsor
University of Turin, Italy
Collaborator
University of Roma La Sapienza
Collaborator
University of Siena
Collaborator
University of Pisa
Collaborator
Istituto Oncologico Veneto IRCCS
Collaborator
University of Catania
Collaborator
Istituto Auxologico Italiano
Collaborator
Source ClinicalTrials.gov