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

INTERVENTION: 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 CONDITION: superficial bladder cancer, carcinoma in situ (CIS) PRIMARY OUTCOME: recurrence‐free survival SECONDARY OUTCOME: overall survival, progression rate, complete response rate in CIS INCLUSION CRITERIA: 1) written informed consent. 2) complete resection of superficial bladder cancer within 6 weeks (with or without CIS). 3) histological diagnosis of transitional cell carcinoma. 4) histological diagnosis of superficial bladder cancer(Ta, T1) or carcinoma in situ (CIS). to fulfill at least one of the requirements (a. ‐ e.) a. 3 (or more) separate tumors b. more than 3cm in tumor diameter c. CIS d. history of twice or more treatments for superficial bladder cancer e. history of superficial bladder cancer within 12 months 5) no medical history of BCG treatment within 12 months and no medical history of plural BCG treatments. 6) no medical history of administration of anticancer drugs or antimetabolic drugs within 4 weeks. 7) normal blood test. to fulfill all requirements (a.‐f.) a. white blood cells: 3300/mm3‐10000/ mm3 b. platelets: more than 10X104/mm3 c. Hb.: more than 9.5g/dl d. AST