Control Group and Maintenance Treatment with Bacillus Calmette-Guerin for Superficial Bladder Cancer: A Prospective Randomized Trial

UMIN ID: C000000292

Registered date:01/12/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: superficial bladder cancer, carcinoma in situ (CIS)
• Date of first enrollment: 2005/12/01
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

BCG instilled once a week for 8 weeks
BCG instilled once a week for 6 weeks, followed by three weekly instillations at month 3, 6, and 12

Outcome(s)

• Primary Outcome: recurrence-free survival
• Secondary Outcome: overall survival, progression rate, complete response rate in CIS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1) invasive bladder cancer or history of invasive bladder cancer 2) malignant tumor in upper urinary tract or malignant tumor in urethra 3) lymph node or distant metastasis 4) injection of anticancer drug for bladder cancer. radiation for bladder cancer 5) immunosupressive glucocorticoid or other immunosupressive treatments 6) immunosupressive diseases 7) active malignant diseases except for bladder cancer 8) active tuberculosis or anti tuberculosis therapy 9) severe bacterial urinary tract infection disease or medical history of severe infection within 4 weeks 10) medical history of severe irritation or severe complications such as cardiovascular disorder, respiratory disease, kidney disease, liver disease or blood disease 11) medical history of BCG allergy 12) contracted bladder 13) interstitial pneumonia or pulmonary fibrosis 14) pregnant woman, nursing mother, woman expecting pregnancy 15) other concerns about BCG therapy (physician's decision)

Related Information

• Primary Sponsor: Oita BCG study group
• Source(s) of Monetary Support: Oita university