MedPath

A prospective randomized study of the comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin for non muscle invasive bladder cancer with intermediate recurrent risk

Not Applicable
Conditions
Bladder Cancer
Registration Number
JPRN-UMIN000022153
Lead Sponsor
Kyoto Prefectural University of Medicine, Department of Urology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
116
Inclusion Criteria

Not provided

Exclusion Criteria

1.Active double cancer (including upper urinary tract carcinoma and prostate carcinoma) 2. CIS, High grade or MIBC confirmed TURBT 3. Previously received BCG intravesical chemotherapy or intravesical chemotherapy within 1 year 4. Serious drug hypersensitivity 5. Active tuberculosis defined by T spot 6. Severe dysfuction of main organs, CHF with NYHA III or IV, asparates aminotransferase and alanine amonotransferase below 3 times as normal values, Hb A1c >= 8.0% 7. Serious viral and bacterial infection 8. Patients the investigators considered to be inappropriate for this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The percentage of adverse effects
Secondary Outcome Measures
NameTimeMethod
2 Year recurrent free rate
© Copyright 2025. All Rights Reserved by MedPath