Reinducing Radioiodine-sensitivity in Radioiodine-refractory DTC Using Lenvatinib (RESET) (NCT04858867) | Clinical Trial Compass
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Reinducing Radioiodine-sensitivity in Radioiodine-refractory DTC Using Lenvatinib (RESET)
Netherlands12 participantsStarted 2022-01-10
Plain-language summary
This is a single-centre open label phase II study evaluating the effect of lenvatinib treatment for restoring radioiodine uptake and retention in radioiodine-refractory (RAI-R) thyroid cancer to warrant I-131 therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years at the time of informed consent
* Histologically or cytologically confirmed DTC (including papillary, follicular or Hürthle Cell carcinoma)
* Progressive (biochemical or anatomic) disease for which lenvatinib is started as standard treatment at the discretion of the treating physician
* Measurable disease at baseline imaging (F-18 FDG PET) according to the definition of the Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) 1.0 with at least one lesion ≥1.0 cm in the longest diameter for a non-lymph node or ≥1.5 cm in the short axis for a lymph node.
* RAI-R disease on structural imaging, defined as any one of the following:
* Metastatic lesions that are not RAI-avid on a diagnostic or intra-therapeutic RAI scanperformed prior to enrolment in the current study
* RAI-avid metastatic lesions which remained stable in size or progressed according to RECIST 1.1 criteria despite RAI treatment. Absence of response is observed during 6-9 months after high dose I-131 therapy.
* No recent treatment for thyroid cancer:
* No prior I-131 therapy is allowed \<6 months prior to initiation of therapy on this protocol (a diagnostic study using \<400 MBq of I-131 is not considered 131I therapy)
* No external beam radiation therapy is allowed \<4 weeks prior to initiation of therapy on this protocol. (Previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does no…
What they're measuring
1
Fraction of RAI-R thyroid cancer patients who are eligible for I-131 therapy after 6- or 12-week lenvatinib treatment
Timeframe: 2-3 months after completed inclusion of all study participants