UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005044 |
|---|---|
| Receipt number | R000005996 |
| Scientific Title | A randomized competitive trial of Angiotensin II Receptor Blocker (ARB) for prevention of tumor recurrence in non-muscle invasive bladder cancer |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2011/08/09 12:27:17 |
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Basic information
Public title
A randomized competitive trial of Angiotensin II Receptor Blocker (ARB) for prevention of tumor recurrence in non-muscle invasive bladder cancer
Acronym
ARB therapy for non-muscle invasive bladder cancer
Scientific Title
A randomized competitive trial of Angiotensin II Receptor Blocker (ARB) for prevention of tumor recurrence in non-muscle invasive bladder cancer
Scientific Title:Acronym
ARB therapy for non-muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of ARB therapy to prevent an intravesical recurrence in non-muscle invasive bladder cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
3-year recurrence-free survival rate
Key secondary outcomes
Safety
Quality of Life
Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARB therapy for non-muscle invasive bladder cancer
Interventions/Control_2
Calcium channel blocker therapy for non-muscle invasive bladder cancer
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. Pathological diagnosis ; urothelial carcinoma.
2. Patients who are initially diagnosed as non-muscle invasive bladder cancer and treated completely by transurethral resection.
3. More than 20 years old at diagnosis.
4. Performance status (ECOG) of the cases should be 0 or 1.
5. Function of important organ should be sufficient.
6. Tolerable for internal use for ARB.
7. Agreement form for this study should be obtained from the patients.
8. Inspection value standard
3000/mm3 <= WBC < 12,000/mm3
Neutrophile ;1,500/mm3<=
Platelet ;100,000/mm3<=
sGOT/sGPT ; Within twice of normal range in respective institutes.
sT-bilirubin; <3mg/dl
Hb; =>9.0g/dls
Creatinin; <2.0mg/dl
Key exclusion criteria
1. Prior therapy of ARB and/or ACE inhibitor.
2. Normal blood pressure
3. Patients with primary CIS.
4. Presence of active other cancers.
Having a severe complications occurred before this study; serious heart failure, renal failure, liver dysfunction, severe infection, and blood trouble.
5. Contraindications for ARB or Calcium channel blocker. (According to attached files of ARB or Calcium channel blocker.)
6. A pregnant women, a woman of breast-feeding, a woman who want to get pregnant.
Presence of severe allergy for medicines.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Oya |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35, shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35, shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
urotanaka@a2.keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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
| 2011 | Year | 04 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 02 | Month | 07 | Day |
Last modified on
| 2011 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005996
