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.
a patient over the age of 20
Patients who are willing and able to complete a written test subject consent/approval for this examination.
Histologically confirmed high-risk NMIBC (according to AUA guidelines; High-grade T1 disease, any recurrent high-grade Ta, high-grade Ta >3 cm, high-grade Ta that is multifocal, any carcinoma in situ, any BCG failure in high-grade patients, any variant histology, any lymphovascular invasion, and any high-grade prostatic urethral involvement) with prior BCG therapy.
The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG
Patient diagnosed with muscle-invasive bladder cancer at TURBT
If upper urinary tract urothelial cancer is accompanied by imaging
If the imaging indicates extravesical involvement (cT3)
Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
Single group
Mitomycin-C
DrugIntravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.
gemcitabine
DrugIntravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.
High 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.
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.
Cystectomy free survival in sequential treatment group.
Defined as the period from the initial TURBT date\* to the time when radical cystomy was performed.
cancer specific survival in sequential treatment group.
Duration from initial TURBT date\* to the time of death from bladder cancer
Overall survival in sequential treatment group.
The period from the initial TURBT date\* to the point of death (regardless of cause)
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National Cancer Center, Korea
Lead sponsor
Korea University Anam Hospital
Collaborator
Pusan National University Hospital
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Seoul St. Mary's Hospital
Collaborator
Chonnam National University Hospital
Collaborator
