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

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2005
INTERVENTION: 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 CONDITION: Superficial Bladder Cancer PRIMARY OUTCOME: Recurrence free survival SECONDARY OUTCOME: Recurrence free rate; Safety 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
Epistemonikos ID: 6b0b4aedb421f23210326ab135bbeb4e6a04cde4
First added on: Aug 21, 2024