UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004378 |
|---|---|
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer
Acronym
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer
Scientific Title
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer
Scientific Title:Acronym
A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
non-muscle invasive bladder cancer (pTa and low grade)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Duration of recurrence-free survival
Key secondary outcomes
Two-year recurrence free survival rate
Safty
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Immediate intravesical instillation of Pirarubicin 30 mg following transurethral resection of bladder cancer
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(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
Key exclusion criteria
(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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
Address
7-5-1, Kusunoki-cho, Kobe
TEL
078-382-6155
uro6155@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyake |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
Address
7-5-1, Kusunoki-cho, Kobe
TEL
078-382-6155
Homepage URL
hideakimiyake@hotmail.com
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2010 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 13 | Day |
Last modified on
| 2015 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005234
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
