Superficial bladder cancer (Ta or T1, Grade1-2)
Conditions
Interventions
A: After TURBT, administering 27mg/41mL of BCG-connaught strain intravesically once a week, 6 times in total
B: After TURBT, administering 13.5mg/40.5mL of BCG-connaught strain intravesically once a w
Sponsors
Kinki University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged between 20 and 85 at the time of registration 2) Patients with Performance Status (P.S.) levels of 0 to 2 [ECOG (Zubrod) score] 3) Patients in whose case all the tumors were removed within 1 month before the first day of administration, and the urinary cytology following TURBT was negative for malignancy. 4) Of patients whose all tumors removed by the TURBT this time was histologically confirmed to be superficial transitional-cell cancer, those who satisfy any of the following conditions. [Primary patients] Stage Ta or T1, G1-2 [Recurrent patients] Stage Ta or T1, G1-2 and the recurrence period between the previous TURBT and the present TURBT was 12 months or longer 5) Patients with no carry-over effects of previous treatments. 6) Patients with sufficient function of the major organs 7) Written informed consent obtained
Exclusion criteria
Exclusion criteria: Patient who meet one of criteria below are excluded. 1) Patients with carcinoma in situ (CIS) 2) Patients with invasive cancer of the muscle layer of the urinary bladder or a history thereof 3) Patients complicated with malignant tumors of upper urinary tract or urethra, or a history thereof 4) Patients with lymph node metastasis or metastasis in other organs 5) Patients who have received intravenous or intraarterial chemotherapy with anticancer drugs or radiotherapy for bladder carcinoma 6) Patients who have been treated with intravesical BCG 7) Patients currently on medications including steroids at immunosuppressive doses 8) Patients with congenital or acquired immunodeficiency 9) Patients with active double cancers 10) Patients with active tuberculosis or currently receiving anti-tuberculosis therapy 11) Patients with serious bacterial urinary tract infection, or a history of serious viral or bacterial infection within 4 weeks before registration 12) Patients with serious hypersensitivity or other serious complications (diseases of heart, lungs, kidneys, liver or blood) 13) Patients with a history of systemic hypersensitivity against BCG 14) Patients with a strongly positive tuberculin response 15) Patients with contracted bladder 16) Patients with interstitial pneumonia or pulmonary fibrosis 17) Pregnant, possibly pregnant or lactating women 18) Other patients assessed to be ineligible by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relation between the incidence of fever (over 37 degrees C) and non-recurrence rate Adverse drug reactions | — |
Countries
Japan
Outcome results
None listed