Randomized Prospective Trial of Intravesical Bacillus Calmette-Guerin Instillation with Low Dose versus Standard Dose for Transitional Cell Carcinoma of the Urinary Bladder

UMIN ID: UMIN000000842

Registered date:05/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Initial or recurrent superficial bladder cancer that cannot be completely resected and carcinoma in situ (CIS) of the bladder.
• Date of first enrollment: 2006/11/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Freeze-dried BCG for intravesical use (Japanese strain) (Immunobladder for intravesical instillation 80 mg/40 mL) will be instilled 8 times.
Freeze-dried BCG for intravesical use (Japanese strain) (Immunobladder for intravesical instillation 40 mg/40 mL) will be instilled 8 times.

Outcome(s)

• Primary Outcome: Complete response rate (CR rate)
• Secondary Outcome: 1) Relapse-free survival (all secondarily enrolled subjects/subjects with CR) 2) Incidence of adverse drug reactions 3) Progression-free survival 4) Achievement rate for instillation frequency 5) Overall survival rate 6) QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1)Active tuberculous lesion or strongly positive tuberculin reaction*. *: Strongly positive tuberculin reaction is defined as redness with a maximum diameter of >= 10 mm accompanied by induration with redness, blister, and necrosis. 2) Active double cancer (including upper urinary tract carcinoma and prostatic urethral cancer) 3) Previously received BCG intravesical instillation therapy 4) History of upper urinary tract carcinoma 5) Previously received systemic intravenous or intra-arterial infusion of an anti-cancer drug or radiation therapy for bladder cancer 6) Previously received TURBT, systemic chemotherapy or intravesical instillation therapy with an anti-cancer drug within 4 weeks prior to biopsy 7) Contracted bladder 8) Serious drug hypersensitivity 9) Previously received local radiation therapy for the bladder 10) Patients receiving pharmacotherapy, including steroids at an immunosuppressive dose 11) Serious viral or bacterial infection 12) Interstitial pneumonia or pulmonary fibrosis 13) Severe cardiac (circulatory), pulmonary, renal, hepatic, or hematopoietic impairment 14) Other serious complications 15) Pregnant or possibly pregnant women 16) Patients the investigator considers to be inappropriate for this study

Related Information

• Primary Sponsor: Study Group for Low-dose BCG Intravesical Instillation Therapy
• Source(s) of Monetary Support: The Waksman Foundation of Japan INC.