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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006861
Receipt No. R000008113
Scientific Title Randomized controlled trial to investigate the retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer following transurethral resection of bladder tumor.
Date of disclosure of the study information 2011/12/09
Last modified on 2011/12/08

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Basic information
Public title Randomized controlled trial to investigate the retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer following transurethral resection of bladder tumor.
Acronym Investigation of retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer.Investigation of retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer.
Scientific Title Randomized controlled trial to investigate the retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer following transurethral resection of bladder tumor.
Scientific Title:Acronym Investigation of retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer.Investigation of retention time of intravesical instillation therapy with pirarubicin for non-muscule invasive bladder cancer.
Region
Japan

Condition
Condition Intermediate risk non-muscle invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigating the retention time of 30 minutes and 120 minutes of intravesical instillation therapy with pirarubicin performed in patients who underwent transurethral resection of bladder tumor. Evaluation criteria are quality of life, safety and effectiveness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Quality of life
Key secondary outcomes Safety
Recurrence-free rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravesical instillation therapy with pirarubicin 30mg a total of 9 times,with the first instillation at the time of transurethral resection of bladder tumor and then 8 times.
A group with a retention time of 30 minutes.
Interventions/Control_2 Intravesical instillation therapy with pirarubicin 30mg a total of 9 times,with the first instillation at the time of transurethral resection of bladder tumor and then 8 times.
B group with a retention time of 120 minutes.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. Intermediate risk non-muscule invasive bladder cancer.
2. PS 0-2
3. Patients who can periodically undergo cystoscopic surveillance of recurrence after surgery.
4. All tumors were resected patients with transurethral resection of bladder.
5. Informed consent on document for this study should be obtained form the patient.
Key exclusion criteria 1. Patients who previously underwent intravesical therapy with BCG.
2. The patients underwent maintenance intravesical therapy of an anticancer agent.
3. Patients with active other malignant disease.
4. Patients with historically or presently disease of upper urinary tract urothelial cell carcinoma.
5. Funcion of all organs are without severe dysfunction.
6. Inappropriate patients for this study judged by the physicians.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Eto
Organization Kumamoto Univeristy
Division name Faculty of Life Sciences, Department of Urology
Zip code
Address 1-1-1 Honjo, Kumamoto-city, Kumamoto
TEL 096-373-5240
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Wada
Organization Kumamoto Univerisity
Division name Faculty of Life Sciences, Department of Urology
Zip code
Address 1-1-1 Honjo, Kumamoto-city, Kumamoto
TEL 096-373-5240
Homepage URL
Email yoshiwad@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto Univeristy
Institute
Department

Funding Source
Organization Kumamoto University
Organization
Division
Category of Funding Organization
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
2011 Year 12 Month 09 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 Open public recruiting
Date of protocol fixation
2011 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 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
2011 Year 12 Month 08 Day
Last modified on
2011 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008113

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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