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

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 - The comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin in NMIBC patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022153

Enrollment

116

Registered

2016-09-01

Start date

2016-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Interventions

Intravesical instillation of 80mg BCG , weekly, 6times Intravesical instillation of 30mg pirarubicin, weekly, 8 times The patients were examined by cystoscopy and urine cytological examination every

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed urothelial carcinoma 2. Confirmed NMIBC with intermediate recurrent risk 3.Performance status 0-2 4. Patients able to be assessed, e.g., by cystoscopy and urinary cytology, on a regular basis 5. Male or female, aged 20-90 years 6. Patient that given written informed consent prior to the start of this study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The percentage of adverse effects	—

Secondary

Measure	Time frame
2 Year recurrent free rate	—

Countries

Japan

Contacts

Public ContactYoshio Naya

Kyoto Prefectural University of Medicine Urology

ynaya@koto.kpu-m.ac.jp0752515595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026