UMIN ID: UMIN000003146
Registered date:08/02/2010
neoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | bladder cancer |
| Date of first enrollment | 2009/09/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 1 course per 3 weeks GEM 800mg/m2 day1,8 , CDDP 70mg/m2 day2, Zometa 4mg day2 Total 2 courses |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome | safety survival(over all survival, progression free survival) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | overt infection. fever(>38 degree) catastrophic complication active double cancer asymptomatic brain metastases pleural effusion pericarium varicella moror parallysis or peripheral nervedisorder drug sensitivity pregnant woman, and have possibility |
Related Information
| Primary Sponsor | Department of Urology, Graduate School of Biomedical Sciences Hiroshima University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Koji Mita, Kanao Kobayashi |
| Address | 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 (Japan) Japan |
| Telephone | 082-257-5242 |
| Affiliation | Graduate School of Biomedical Sciences, Hiroshima University Department of Urology |
| scientific contact | |
| Name | Akio Matsubara |
| Address | 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 (Japan) Japan |
| Telephone | 082-257-5242 |
| Affiliation | Graduate School of Biomedical Sciences, Hiroshima University Department of Urology |