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

UMIN ID: C000000266

Registered date:16/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Superficial Bladder Cancer
• Date of first enrollment: 2005/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

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

Outcome(s)

• Primary Outcome: Recurrence free survival
• Secondary Outcome: Recurrence free rate Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Urolofgy, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
• Source(s) of Monetary Support: None