UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009967 |
|---|---|
| Receipt number | R000011673 |
| Scientific Title | Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer. |
| Date of disclosure of the study information | 2013/02/07 |
| Last modified on | 2013/02/05 19:11:30 |
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Basic information
Public title
Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer.
Acronym
Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer.
Scientific Title
Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer.
Scientific Title:Acronym
Prevention of recurrence undergoing additional intravesical therapy with pirarubicin for non-muscule invasive bladder cancer.
Region
| Japan |
Condition
Condition
Non-muscle invasive bladder cancer (intermediate-risk patients)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate recurrence preventive effects and safety of intravesical infusion therapy administered immediately after TURBT followed by additional pirarubicin therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Duration of recurrence-free survival
Key secondary outcomes
Two-year recurrence free survival rate
Safty
Base
Study type
Interventional
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravesical infusion of pirarubicin 30mg immediately after TURBTand every one time at 3,6,9,12months later.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Non-muscle invasive bladder cancer (pTa-1,G1-2/low grade).
(exept for first-time case & single tumour & G1/low grade & tumour diameter<3cm)
(2) Curative resection of all visible tumors can be performed.
(3) No concurrent CIS
(4) Patients must have functioning organs
(5) Performance status scale 0-2
(6) Patients must give written informed consent
Key exclusion criteria
(1) Active multiple cancers
(2) Patients with historically or presently disease of upper urinary tract urothelial cell carcinoma.
(3) Target at BCG therapy (unrelated 2nd TUR)
(4) Funcion of all organs are without severe dysfunction.
(5) Lymph node metastasis or ogan metastasis
(6) After TURBT,patients who didn`t undergo intravesical therapy with pirarubicin.
(7) Patients who previously underwent intravesical therapy with BCG.
(8) Inappropriate patients for this study judged by the physicians
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe university graduate school of medicine
Division name
Urology
Zip code
Address
7-5-1, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe university graduate school of medicine
Division name
Department of Urology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku,
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology
Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 02 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2013 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011673
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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