A randomized study of intravesical BCG therapy for superficial bladder cancer -The comparative study for low doses of BCG treatment-

UMIN ID: C000000364

Registered date:24/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Superficial bladder cancer (Ta or T1, Grade1-2)
• Date of first enrollment: 2006/01/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 week, 6 times in total
C: TURBT alone

Outcome(s)

• Primary Outcome: recurrence-free survival
• Secondary Outcome: Relation between the incidence of fever (over 37 degrees C) and non-recurrence rate Adverse drug reactions

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Kinki University School of Medicine
• Source(s) of Monetary Support: None