To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma
There have been no standard treatment in non-clear cell renal cell carcinoma. Retrospective studies showed sunitinib or sorafenib might be active in non-clear cell renal cell carcinoma, especially papillary type and chromophobe type. This study is to evaluate efficacy and safety of sunitinib in this group of patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Sunitinib 50 mg D1-D28 every 6 weeks
Asan Medical Center
Seoul, Seoul, South Korea
Response rate
Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category.
Time frame: up to 12 months
Progression free survival
Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first.
Time frame: up to 24 months
overall survival
Time frame: up to 36 months
Safety
Safety will be assessed using CTCAE v.3.0
Time frame: up to 24 months
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