RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 667
- 主要终点
- Time to symptomatic progression (TTSP) from study entry
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MKI patients
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.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
MKI patients
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.
干预措施: Other Multikinase inhibitors (Drug)
non-MKI patients
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.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
non-MKI patients
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.
干预措施: Other Multikinase inhibitors (Drug)
结局指标
主要结局
Time to symptomatic progression (TTSP) from study entry
时间窗: 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.
次要结局
- Overall survival (OS) from time of study entry(Up to 6 years)
- Progression free survival (PFS) from time of study entry(Up to 6 years)
- OS from time of being diagnosed as radioactive iodine (RAI) refractory(Up to 6 years)
- Post-progression survival (PPS) from time of symptomatic progression(Up to 6 years)
- PFS from initiation of first MKI(Up to 6 years)
- OS from initiation of any systemic treatment regimen(Up to 6 years)
- OS from initiation of sorafenib(Up to 6 years)
- PFS from initiation of sorafenib(Up to 6 years)
- Daily dose of sorafenib per patient throughout the treatment period(Up to 6 years)
- OS from initiation of the first Multikinase Inhibitor (MKI)(Up to 6 years)
- PFS from initiation of any systemic treatment regimen(Up to 6 years)
- Duration of each systemic treatment regimen(Up to 6 years)
- 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)
- Number of adverse events during treatment with sorafenib(Up to 6 years)