This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Sunitinib 50 mg PO 2 weeks followed by 1 week rest
Sunitinib 50 mg PO 4 weeks followed by 2 week rest
Daegu Catholic University Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.
Time frame: 12 months
Overall response rate
RECIST v.1.1 will be used to assess tumor responses
Time frame: 6 months
quality of life
EORTC QLQ C30 and EQ5D will be used to assess the quality of life
Time frame: 12 months
Progression free survival
Time frame: 12 months
Overall survival
Time frame: 36 months
Adverse events
CTC AE v.3.0
Time frame: about 12 months
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