Clinical trial · Observational
An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors
RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
NCT02303444CI-TRIAL-00066994RIFTOS MKIcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of the study was to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Other Multikinase inhibitors | Drug | — | UNRESOLVED |
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- MKI patients
- description
- Asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry. For patients on sorafenib, treatment start and stop dates will be collected along with any adverse events observed.
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- Drug: Other Multikinase inhibitors
- label
- non-MKI patients
- description
- Asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry. For patients on sorafenib, treatment start and stop dates will be collected along with any adverse events observed.
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- Drug: Other Multikinase inhibitors
Primary outcomes (1)
- measure
- Time to symptomatic progression (TTSP) from study entry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma) * DTC refractory to RAI * Radiological progression and preferably according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * No symptoms due to DTC * \>/=1cm diameter of lesion confirmed by radiological exam * Life expectancy of at least 6 months Exclusion Criteria: * Plan to be treated according to a clinical trial protocol for intervention including a locoregional therapy or systemic therapy * Previous treatment with MKIs for advanced disease * Hospice patients
References
Publications (4)
- DERIVEDGianoukakis AG, Choe JH, Bowles DW, Brose MS, Wirth LJ, Owonikoko T, Babajanyan S, Worden FP. Real-world practice patterns and outcomes for RAI-refractory differentiated thyroid cancer. Eur Thyroid J. 2024 Jan 24;13(1):e230039. doi: 10.1530/ETJ-23-0039. Print 2024 Feb 1. PMID 38096102
- DERIVEDBrose MS, Smit JWA, Lin CC, Tori M, Bowles DW, Worden F, Shen DH, Huang SM, Tsai HJ, Alevizaki M, Peeters RP, Takahashi S, Rumyantsev P, Guan R, Babajanyan S, Ozgurdal K, Sugitani I, Pitoia F, Lamartina L. Multikinase Inhibitors for the Treatment of Asymptomatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Global Noninterventional Study (RIFTOS MKI). Thyroid. 2022 Sep;32(9):1059-1068. doi: 10.1089/thy.2022.0061. PMID 35950621
- DERIVEDPorcelli T, Luongo C, Sessa F, Klain M, Masone S, Troncone G, Bellevicine C, Schlumberger M, Salvatore D. Long-term management of lenvatinib-treated thyroid cancer patients: a real-life experience at a single institution. Endocrine. 2021 Aug;73(2):358-366. doi: 10.1007/s12020-021-02634-z. Epub 2021 Feb 3. PMID 33537956
- DERIVEDBrose MS, Smit J, Lin CC, Pitoia F, Fellous M, DeSanctis Y, Schlumberger M, Tori M, Sugitani I. Timing of multikinase inhibitor initiation in differentiated thyroid cancer. Endocr Relat Cancer. 2017 May;24(5):237-242. doi: 10.1530/ERC-17-0016. Epub 2017 Mar 7. PMID 28270435