Thyroid Neoplasms
Conditions
Keywords
Progressive radioactive iodine refractory differentiated thyroid carcinoma
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.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.
DRUGOther Multikinase inhibitors
Patients can get MKIs at any time during study.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to symptomatic progression (TTSP) from study entry | Up to 6 years | TTSP is defined as the time interval from the day of study entry to the date of first symptomatic progression. Patients who do not have a symptomatic progression at the time of analysis will be censored at the date of their last evaluable assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) from time of study entry | Up to 6 years | Defined as the time interval from the date of study entry to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation. |
| OS from time of being diagnosed as radioactive iodine (RAI) refractory | Up to 6 years | Defined as the time interval from the day of being diagnosed as RAI refractory to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive. |
| Post-progression survival (PPS) from time of symptomatic progression | Up to 6 years | Defined as the time interval from the date of symptomatic progression to death due to any cause. Patients without symptomatic progression will be excluded from analysis and patients who are alive at the time of analysis will be censored at the last date when they were known to be alive. |
| OS from initiation of the first Multikinase Inhibitor (MKI) | Up to 6 years | Defined as the time interval from the day of start of the first MKI to death due to any cause. Patients alive at the time of analysis will be censored at the last date when they were known to be alive. |
| PFS from initiation of first MKI | Up to 6 years | Defined as the time interval from the day of start of first MKI to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation. |
| OS from initiation of any systemic treatment regimen | Up to 6 years | Defined as the time interval from the date of start of any systemic treatment regimen to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive. |
| Overall survival (OS) from time of study entry | Up to 6 years | Defined as the time interval from the date of study entry to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive. |
| Duration of each systemic treatment regimen | Up to 6 years | Defined as the time interval from the day of start of a treatment to the date of permanent discontinuation of a treatment (regardless of the reason for discontinuation including death). It includes interruption or drug holiday. |
| 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 | Up to 6 years | In case of Clinical Progression the CRF will ask for the presence of specific symptoms. |
| OS from initiation of sorafenib | Up to 6 years | Defined as the time interval from the day of start of sorafenib to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive. |
| PFS from initiation of sorafenib | Up to 6 years | Defined as the time interval from the date of start of sorafenib to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation. |
| Daily dose of sorafenib per patient throughout the treatment period | Up to 6 years | — |
| Number of adverse events during treatment with sorafenib | Up to 6 years | — |
| PFS from initiation of any systemic treatment regimen | Up to 6 years | Defined as the time interval from the date of start of any systemic treatment regimen to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation. |
Countries
Algeria, Argentina, Brazil, Egypt, France, Germany, Greece, India, Japan, Lebanon, Mexico, Netherlands, Philippines, Russia, Saudi Arabia, Spain, Taiwan, Turkey (Türkiye), United States
Outcome results
None listed