Predictive Factors of Long-term Survivor (LTS) of Patients With Recurrent or Metastatic, Radio-iodine Resistant Differentiated Thyroid Cancer (RRDTC) After Lenvatinib: a Multicenter Study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele
- Trial code
- NCT07927764
- Record updated
- 2026. november 10.
- Original description
This is an observational, pharmacological, retrospective, multicenter study and involves a total of 4 enrolling centers. This study aims to demonstrate that, in real-world clinical practice, the survival of RAI-refractory patients treated with Lenvatinib is significantly greater than the 30 months described by Gianoukakis et al., reaching-and in some cases exceeding-5 years.Read full original descriptionShow less
This is an observational, pharmacological, retrospective, multicenter study and involves a total of 4 enrolling centers. This study aims to demonstrate that, in real-world clinical practice, the survival of RAI-refractory patients treated with Lenvatinib is significantly greater than the 30 months described by Gianoukakis et al., reaching-and in some cases exceeding-5 years.
Inclusion: Adult patients (≥ 18 years of age); Patients capable of providing informed consent; Patients with a diagnosis of differentiated thyroid carcinoma confirmed by cytological or histological examination, showing disease progression within the last 12 months; Patients with radioiodine-refractory differentiated thyroid carcinoma (i.e., patients with one or more metastatic lesions without RAI uptake; patients with progressive lesions lacking RAI uptake within the last 12 months; or patients who have received a cumulative RAI dose > 600 mCi); ECOG performance status of 0-2; Patients who are treatment-naïve or with disease recurrence following first-line therapy; Patients with blood pressure ≤ 150/90 mmHg and adequate bone marrow, liver, and renal function (creatinine clearance > 30 mL/min calculated using the Cockcroft-Gault formula).
Exclusion: Patients previously treated with Lenvatinib; Patients with a positive medical history of congestive heart failure, unstable angina, ischemic heart disease, ischemic stroke, or cardiac arrhythmias in the last 6 months; Patients with a prolonged QT interval on pre-treatment ECG; Patients with medullary or anaplastic thyroid carcinoma; Patients with impaired renal function or proteinuria (urinary protein >1 g/24 h).