Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe incidence of bladder cancer in the first 12 month following nephroureterectomy
Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.
Time frame: 12 month
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 day, 1 month and 12 month
questionnaire for quality of life
e.g QLQ C-30
Time frame: baseline, 1 month and 12 month
progression-free survival
progression-free survival
Time frame: 12 month
cancer-specific survival
cancer-specific survival
Time frame: 12 month
overall survival
overall survival
Time frame: 12 month
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