UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006861 |
|---|---|
| Receipt number | 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 16:10:20 |
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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
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
yoshiwad@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto Univeristy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008113
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| Registered date | File name |
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