Non-muscle invasive bladder cancer(Ta,T1)
Conditions
Interventions
Standard dose(80mg)of BCG(Bacillus Calmette-Guerin)instillation induction therapy
BCG induction(80mg)and low-dose(40mg)maintenance therapy
Sponsors
Department of Urology, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Complete resection of non-muscle invasive bladder cancer by TURBT 2)Histological diagnosis of urothelial carcinoma. 3)To be fallen into at least one of the following categories. (first diagnosed) More than two tumors (recurrent) More than two tumors -History of twice or more treatments for superficial bladder cancer -History of non-muscle invasive bladder cancer within 12 months 4)ECOG Performance Status is from 0to2 5)20 to 80 years of age,inclusive 6)Normal blood test.to fulfill all requirements(a.-f.) a.Hb.>=10g/dL b.platelets>=10*10^4/mm c.white blood cells>= 3000/mm^3 d.AST,ALT,and ALP:withindoublestandard-value e.total bilirubin<=2.0mg/dL f.serum creatinine<=1.5mg/dL 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active tuberculosis or significant positive on PPD test 2)History of CIS 3)History of MIBC(Muscle Invasive Bladder Cancer) 4)History of malignant tumor in upper urinary tract 5)Active multiple primary cancer (including upper urethral cancer or malignant tumor in prostatic urethra) 6)History of BCG instillation 7)Received anti-cancer drug instillation into the bladder within four weeks before TURBT 8)History of intravenous or intra-arterial systemic chemotherapy of anti-cancer drug, or radiation therapy 9)Severe infection disease in urinary tract 10)History of severe bacterial or viral infection within four weeks 11)Immunosuppressive glucocorticoid or other immunosuppressive treatments 12)Immunosuppressive diseases 13)Interstitial pneumonia or pulmonary fibrosis 14)Contracted bladder 15)Severe complications such as cardiovascular disorder, respiratory disease, kidney disease, liver disease or blood disease 16)Other severe diseases 17)History of severe drug allergy 18)Pregnant woman, nursing mother, woman expecting pregnancy 19)Other concerns about BCG therapy (physician's decision)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival Compliance of protocol treatment Adverse events | — |
Countries
Japan
Contacts
Public ContactAkira Yokomizo
Graduate School of Medical Sciences, Kyushu University Department of Urology
Outcome results
None listed