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Brief Title: Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
Official Title: Prospective Cohort Study of Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Moderate-high Recurrence and Progression Risks of Muscle-invasive Bladder Cancer
Study ID: NCT02716961
Brief Summary: It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC.
Detailed Description: Prevention of the post-transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder cancer(NMIBC) is still a difficult problem. NMIBC was classified as low, moderate and high risk patients. Moderate-high risk NMIBC contained those are multiple, recurrent, II-III grade, tumor diameter \>3cm, invasive to submucosa and associated with carcinoma in situ. For those patients, no matter which treatment was conducted, for example, exchanging instillation drugs, increasing medicine dose, appending adjuvant drugs and prolonging instillation time, would not improve the prognosis of these patients. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. For muscle invasive bladder cancer patients, radical cystectomy with neoadjuvant chemotherapy will improve patients' tumor grade and increase overall survival and disease specific survival rate.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC. In addition, we also would like to investigate the improvement of life quality after TURBT of moderate-high risk NMIBC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The first affiliated hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Name: Qiang Lu, PhD
Affiliation: The First Affiliated Hospital with Nanjing Medical University
Role: PRINCIPAL_INVESTIGATOR