NIPH Clinical Trials Search

UMIN ID: C000000266

Registered date:16/10/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedSuperficial Bladder Cancer
Date of first enrollment2005/10/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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


Primary OutcomeRecurrence free survival
Secondary OutcomeRecurrence free rate Safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients 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

Related Information


public contact
Name Tomoyasu Tsushima
Address 1711-1,Tamasu,Okayama,701-1192,Japan Japan
Telephone 086-294-9911
Affiliation NHO Okayama Medical Center Department of Urology
scientific contact
Name Hiromi Kumon
Address 2-5-1,Shikata-cho,Okayama,700-8558,Japan Japan
Telephone 086-235-7151
Affiliation Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Urology