The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
Phase 2 clinical, multi-institutional, open assignment prospective study Primary Outcome Measures: 1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups. Secondary Outcome Measures: Progression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.
Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.
National Cancer Center
Goyang-si, South Korea
RECRUITINGHigh risk Recurrent free survival in sequential treatment group.
Time from initial TURBT\* to first histologically confirmed recurrence of high-risk NMIBC or disease progression (per PFS definition), whichever occurs first.
Time frame: 1year
Progression free survival in sequential treatment group.
defined as the period from the initial TURBT date\* to the time when T stage progresses (e.g., Ta\>T1, CIS\>T1) (PFS1) or muscle invasive bladder cancer (T2 or higher) was first biopsy confirmed (PFS2) or imagingally diagnosed with metastasis to bladder cancer.
Time frame: 1year
Cystectomy free survival in sequential treatment group.
Defined as the period from the initial TURBT date\* to the time when radical cystomy was performed.
Time frame: 1year
cancer specific survival in sequential treatment group.
Duration from initial TURBT date\* to the time of death from bladder cancer
Time frame: 1year
Overall survival in sequential treatment group.
The period from the initial TURBT date\* to the point of death (regardless of cause)
Time frame: 1year
Safety of sequential treatment.
The first safety analysis is conducted on test subjects who have developed toxicity in accordance with CTCAE standards. In particular, urinary disorders such as urinary tract infections and acute urination that occurred after injection of drugs into the bladder are evaluated.
Time frame: 2year
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