UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011441 |
|---|---|
| Receipt number | 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 10:48:12 |
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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
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
Sponsor or person
Institute
Osaka University Graduate School of Medicine,Department of Organ Specific Regulation (Urology)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013368
