Clinical trial NCT02303444: An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors
Official title: RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Neoplasms
Keywords: Progressive radioactive iodine refractory differentiated thyroid carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-12-01
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any setting that provides treatment for progressive asymptomatic RAI refractory DTC

Brief summary: 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.

Detailed description: The primary objective of this study was to compare time to symptomatic progression (TTSP) from study entry in asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry with that of asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry.

Eligibility criteria: 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

Primary outcomes:
measure: Time to symptomatic progression (TTSP) from study entry
timeFrame: Up to 6 years
Secondary outcomes:
measure: Overall survival (OS) from time of study entry
timeFrame: Up to 6 years
measure: Progression free survival (PFS) from time of study entry
timeFrame: Up to 6 years
measure: OS from time of being diagnosed as radioactive iodine (RAI) refractory
timeFrame: Up to 6 years
measure: Post-progression survival (PPS) from time of symptomatic progression
timeFrame: Up to 6 years
measure: OS from initiation of the first Multikinase Inhibitor (MKI)
timeFrame: Up to 6 years
measure: PFS from initiation of first MKI
timeFrame: Up to 6 years
measure: OS from initiation of any systemic treatment regimen
timeFrame: Up to 6 years
measure: PFS from initiation of any systemic treatment regimen
timeFrame: Up to 6 years
measure: Duration of each systemic treatment regimen
timeFrame: Up to 6 years
measure: Response assessment to each systemic treatment regimen according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression", and "Not evaluable at this visit"
timeFrame: Up to 6 years
measure: OS from initiation of sorafenib
timeFrame: Up to 6 years
measure: PFS from initiation of sorafenib
timeFrame: Up to 6 years
measure: Daily dose of sorafenib per patient throughout the treatment period
timeFrame: Up to 6 years
measure: Number of adverse events during treatment with sorafenib
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Plantation
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Bronx
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Multiple Locations
country: Algeria
city: Multiple Locations
country: Argentina
city: Multiple Locations
country: Brazil
city: Multiple Locations
country: Egypt
city: Multiple Locations
country: France
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Greece
city: Multiple Locations
country: India
city: Multiple Locations
country: Japan
city: Multiple Locations
country: Lebanon
city: Multiple Locations
country: Mexico
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Philippines
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Saudi Arabia
city: Multiple Locations
country: Spain
city: Multiple Locations
country: Taiwan
city: Multiple Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Brose 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.
citation: Porcelli 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.
citation: Brose 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.