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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000257
Receipt No. R000000321
Scientific Title 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
Date of disclosure of the study information 2005/09/30
Last modified on 2008/04/03

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Basic information
Public title 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
Acronym 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
Scientific Title 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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Superficial bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare six times epirubicin instillation for 2.5 months with six times epirubicin instillation for two weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 40mg Epirubicin / 40ml sailine weekly instillation for two weeks, then bi-weekly instillation for 8weeks
Interventions/Control_2 40mg Epirubicin / 40ml sailine three daily instillation a week for two weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pathologically confirmed superficial trancitional cell carcinoma of the bladder (Ta or T1, G1 or G2)
After TURBT
Primary and multiple tumor or recurrent tumor
Written informed consented
Key exclusion criteria Synchronous CIS
G3 tumor
Severe complication
History of allergy for Epirubicin
Active infection
Active synchronous malignancy
History of upper urinary tract malignancies
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Hirao MD
Organization Nara Medical University
Division name Department of Urology
Zip code
Address Nara
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Akaza MD
Organization University of Tsukuba
Division name Department of Urology
Zip code
Address
TEL 029-853-3223
Homepage URL
Email

Sponsor
Institute Japanese Urological Cancer Research Group
Institute
Department

Funding Source
Organization Osaka Cancer Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 30 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 No longer recruiting
Date of protocol fixation
2001 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2002 Year 05 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 30 Day
Last modified on
2008 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000321

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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