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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011441
Receipt No. R000013368
Scientific Title Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer
Date of disclosure of the study information 2013/08/10
Last modified on 2013/08/10

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Basic information
Public title Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer
Acronym Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer
Scientific Title Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer
Scientific Title:Acronym Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer
Region
Japan

Condition
Condition Non-muscle invasive bladder cancer
Classification by specialty
Urology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate primary recurrence preventive effects of intravesical infusion therapy administered immediately after TURBT for Ta T1 non-muscle invasive bladder cancer(prospective study)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The period from a 1st TURBT to the 1st recurrence (Duration of primary recurrence-free survival)
Key secondary outcomes The period from a 1st TURBT to the 2nd recurrence
The period from a 2nd TURBT to the 2nd recurrence
Safety

Base
Study type

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 intravesical instillation of pirarubicin 30mg within 24 hours after TURBT
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Non-muscle invasive bladder cancer whom central pathology has diagnosis
(2) Curative resection of all visible tumors can be performed.
(3) Sufficient organ functions.
(4) ECOG performance status (PS) of 0,1 or 2
(5) 20years old and over
(6) Written informed consent
Key exclusion criteria (1) Not undergoing TURBT
(2) Target at 2ndTUR or BCG therapy
(3) Patients with historically or presently disease of upper urinary tract urothelial cell carcinoma.
(4) Presence of risk perforans bladder or rebleeding by wide TURBT
(5) Presence of active other cancers.
(6) Funcion of all organs are without severe dysfunction.
(7) Lymph node metastasis or ogan metastasis
(8) After TURBT,patients didn`t undergo intravesical therapy with pirarubicin.
(9) Inappropriate patients for this study judged by the physicians
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Nonomura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Zip code
Address 2-2 yamada-oka, Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motohide Uemura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Zip code
Address 2-2 yamada-oka, Suita, Osaka
TEL 81668793531
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of Medicine,Department of Organ Specific Regulation (Urology)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 10 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 10 Day
Last modified on
2013 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013368

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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