Randomized Phase II trial of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors.
Not Applicable
- Conditions
- pper urinary tract urotherial tumor
- Registration Number
- JPRN-UMIN000004039
- Lead Sponsor
- Tohoku University School of Medicine,Department of Urology
- Brief Summary
Seventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)The patient having a grave complication 2) Active cancer except upper urinary tract urotherial tumors is the patient 3)In addition, the patient whom we intended for it, and it was judged judgment of a doctor to be inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bladder recurrence rate
- Secondary Outcome Measures
Name Time Method