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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004378
Receipt No. 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

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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
Email 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
Email hideakimiyake@hotmail.com

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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