Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)
Phase 3
- Conditions
- High grade T1 bladder cancer
- Registration Number
- JPRN-UMIN000006390
- 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
- 260
Inclusion Criteria
Not provided
Exclusion Criteria
First registration (no exclusion criteria at second registration) 1. Simultaneous or metachronous (within 5 years) double cancers. 2. Infectious disease (including tuberculosis) to be treated. 3. Body temperature of 38C or higher. 4. Positive anti-HIV antibody. 5. Women during pregnancy or breast-feeding. 6. Psychiatric diseases. 7. Systemic and continuous steroids medication. 8. History of severe brain ischemia or myocardial infarction within 6 months. 9. History of systemic anaphlactoid reaction for BCG.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relapse-free survival (except Tis or Ta intravesical recurrence)
- Secondary Outcome Measures
Name Time Method overall survival, metastasis-free survival with bladder preserved, annual intravesical relapse-free survival rate, annual proportion of T2 or deeper relapse-free survival, adverse events, serious adverse events