UMIN ID: C000000257
Registered date:30/09/2005
Randomized study comparing six times of epirubicin instillation for 2.5 months with six times for two weeks in superficial bladder cancer after transurethral resection of bladder tumor
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Superficial bladder cancer |
| Date of first enrollment | 2002/05/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 40mg Epirubicin / 40ml sailine weekly instillation for two weeks, then bi-weekly instillation for 8weeks 40mg Epirubicin / 40ml sailine three daily instillation a week for two weeks |
Outcome(s)
| Primary Outcome | Recurrence |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Synchronous CIS G3 tumor Severe complication History of allergy for Epirubicin Active infection Active synchronous malignancy History of upper urinary tract malignancies |
Related Information
| Primary Sponsor | Japanese Urological Cancer Research Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Osaka Cancer Research Foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hideyuki Akaza MD |
| Address | Japan |
| Telephone | 029-853-3223 |
| Affiliation | University of Tsukuba Department of Urology |
| scientific contact | |
| Name | Yoshihiko Hirao MD |
| Address | Nara Japan |
| Telephone | |
| Affiliation | Nara Medical University Department of Urology |