Randomized Controlled Trail on Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer Comparing Single and Two Times Instillation

Randomized Controlled Trail on Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer Comparing Single and Two Times Instillation - Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000266

Enrollment

200

Registered

2005-10-16

Start date

2005-10-01

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

Superficial Bladder Cancer

Interventions

Single postoperative instillation of Pirarubicin (30 mg/50 mL) immediately after TUR-Bt Two times postoperative instillations of Pirarubicin immediately after and one day after TUR-Bt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with stage Ta or T1 superficial bladder cancer Patients with single tumor (primary/single, recurrent/single)(In recurrent cases, although patients who have been treated with intravesical instillation of anticancer agents (including all anticancer agents except for BCG) are eligible, the intravesical chemotherapy must have been conducted more than 4 weeks before) Pathologically confirmed urothelial carcinoma (Because no histopathological diagnosis had been made at the time of registration, eligibility can be judged at the time of the histopathological diagnosis) Patients with complete tumor resection by TUR-Bt(It shall be judged during operation whether the tumor has been completely resected) Patients who can undergo cytoscopy periodically, and in whom the presence or absence of recurrence can be monitored Patients age 20 and over Patients from whom written informed consent has been obtained

Exclusion criteria

Exclusion criteria: Patients with prior history of BCG therapy Patients with CIS, or treatment history of CIS Patients with treatment history of invasive bladder carcinoma Patients with extravesical lesions (in the upper urinary tract and urethra), or past history of related treatment Patients with severe impairments in the bone marrow, liver, kidney or cardiac function Patients with active double cancer Patients who are judged not to be eligible by the physician in charge

Design outcomes

Primary

Measure	Time frame
Recurrence free survival	—

Secondary

Measure	Time frame
Recurrence free rate Safety	—

Countries

Japan

Contacts

Public ContactTomoyasu Tsushima

NHO Okayama Medical Center Department of Urology

tsushima@okayamamc.jp086-294-9911

Outcome results

None listed

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