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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005044
Receipt No. 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

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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
Email

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
Email urotanaka@a2.keio.jp

Sponsor
Institute Keio University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005996

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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