Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Cancer | — | UNRESOLVED | — |
| Gender | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Gender difference in Safety profile of lenvatinib treatment
- timeFrame
- 1 year
- description
- Difference in lenvatinib dose reduction between male and female patients
Secondary outcomes (3)
- measure
- Gender difference in lenvatinib side effects incidence
- timeFrame
- 1 year
- description
- Difference in number of lenvatinib side effects between male and female patients according to CTCAE 5.0
- measure
- Gender difference in lenvatinib response rate
- timeFrame
- 1 year
- description
- Difference in lenvatinib response rate (CR+PR) according to RECIST response evaluation criteria 1.1 in male and female patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with refractory iodine DTC treated with lenvatinib * Signed written informed consent Exclusion Criteria: \- Age \< 18 years
References
Publications (0)
Data not yet available