Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III)
Phase 3
- Conditions
- pper tract urothelial carcinoma
- Registration Number
- JPRN-UMIN000024267
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
Not provided
Exclusion Criteria
First registration (no exclusion criteria at second registration) 1. Synchronous or metachronous (within 5 years) malignancies. 2. Infectious disease requiring systemic treatment. 3. Pyrexia of 38 degrees centigrade or higher. 4. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 5. Severe psychological disorder. 6. Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7. History of abnormal cardiac function or having received the limit dose of medications with cardiac toxicity such as anthracyclines. 8. Positive HIV antibody.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relapse-free survival
- Secondary Outcome Measures
Name Time Method overall survival, intravesical relapse-free survival, adverse events