Unique ID issued by UMIN | UMIN000004378 |
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Receipt number | R000005234 |
Scientific Title | A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer |
Date of disclosure of the study information | 2010/10/21 |
Last modified on | 2015/04/13 17:17:44 |
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer
Japan |
non-muscle invasive bladder cancer (pTa and low grade)
Urology |
Malignancy
NO
Clinical investigation of efficacy of a single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of low-risk non-muscle invasive bladder cancer
Safety
Confirmatory
Explanatory
Phase I,II
Duration of recurrence-free survival
Two-year recurrence free survival rate
Safty
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
Immediate intravesical instillation of Pirarubicin 30 mg following transurethral resection of bladder cancer
Not applicable |
Not applicable |
Male and Female
(1) non-muscle invasive bladder cancer (pTa and low grade).
(2) Curative resection of all visible tumor can be performed.
(3) non-muscle invasive bladder cancer without any CIS element
(4) Function of all organs are within normal range
(5) ECOG performance status, 0-2
(1) patients with duplex of active other malignant disease.
(2) Patients with history or present disease of upper urinary tract utotherial carcinoma.
(3) Patients with severe disfunction of renal, liver, hematopoietic or heart.
(4) Patients with history of allergic reaction against doxorubicin or epirubicin
80
1st name | |
Middle name | |
Last name | Masato Fujisawa |
Kobe University Graduate School of Medicine
Division of Urology
7-5-1, Kusunoki-cho, Kobe
078-382-6155
uro6155@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Hideaki Miyake |
Kobe University Graduate School of Medicine
Division of Urology
7-5-1, Kusunoki-cho, Kobe
078-382-6155
hideakimiyake@hotmail.com
Kobe University Hospital
none
Other
NO
神戸大学医学部附属病院
2010 | Year | 10 | Month | 21 | Day |
Unpublished
Preinitiation
2010 | Year | 10 | Month | 21 | Day |
2010 | Year | 11 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2010 | Year | 10 | Month | 13 | Day |
2015 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005234
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