superficial bladder cancer, carcinoma in situ (CIS)
Conditions
Interventions
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
Sponsors
Oita BCG study group
Eligibility
Sex/Gender
All
Inclusion criteria
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(GOT) and ALT(GPT): within double standard-value e. total bilirubin: less than 2.0mg/dl f. creatinine: less than1.5mg/dl 8) age 20-79 years 9) Performance Status (PS): 0-2(ECOG)
Exclusion criteria
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression rate, complete response rate in CIS | — |
Countries
Japan
Contacts
Public ContactFuminori Sato, MD, PhD
Oita BCG study group Department of Oncological Science (Urology), Faculty of Medicine, Oita university
Outcome results
None listed