A randomized control study to evaluate the prevention of recurrence and the safety of BCG (Bacillus Calmette-Guerin) instillation therapies between induction alone and induction + low-dose maintenance in non-muscle invasive bladder cancer

Phase 3

• Conditions: on-muscle invasive bladder cancer(Ta,T1)

• Registration Number: JPRN-UMIN000010331
• Lead Sponsor: Department of Urology, Graduate School of Medical Sciences, Kyushu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-28
• Study Completion: 2019-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified