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Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer.

Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer. - Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009967
Enrollment
110
Registered
2013-02-07
Start date
2013-04-01
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

Non-muscle invasive bladder cancer (intermediate-risk patients)

Interventions

Intravesical infusion of pirarubicin 30mg immediately after TURBTand every one time at 3,6,9,12months later.

Sponsors

Department of Urology Kobe university graduate school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Non-muscle invasive bladder cancer (pTa-1,G1-2/low grade). (exept for first-time case & single tumour & G1/low grade & tumour diameter<3cm) (2) Curative resection of all visible tumors can be performed. (3) No concurrent CIS (4) Patients must have functioning organs (5) Performance status scale 0-2 (6) Patients must give written informed consent

Exclusion criteria

Exclusion criteria: (1) Active multiple cancers (2) Patients with historically or presently disease of upper urinary tract urothelial cell carcinoma. (3) Target at BCG therapy (unrelated 2nd TUR) (4) Funcion of all organs are without severe dysfunction. (5) Lymph node metastasis or ogan metastasis (6) After TURBT,patients who didn`t undergo intravesical therapy with pirarubicin. (7) Patients who previously underwent intravesical therapy with BCG. (8) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

MeasureTime frame
Duration of recurrence-free survival

Secondary

MeasureTime frame
Two-year recurrence free survival rate Safty

Countries

Japan

Outcome results

None listed

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