Control Group and Maintenance Treatment with Bacillus Calmette-Guerin for Superficial Bladder Cancer: A Prospective Randomized Trial
- Conditions
- superficial bladder cancer, carcinoma in situ (CIS)
- Registration Number
- JPRN-C000000292
- Lead Sponsor
- Oita BCG study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 110
Not provided
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method recurrence-free survival
- Secondary Outcome Measures
Name Time Method overall survival, progression rate, complete response rate in CIS