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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022153
Receipt No. R000025528
Scientific Title A prospective randomized study of the comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin for non muscle invasive bladder cancer with intermediate recurrent risk
Date of disclosure of the study information 2016/09/01
Last modified on 2016/04/30

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Basic information
Public title A prospective randomized study of the comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin for non muscle invasive bladder cancer with intermediate recurrent risk
Acronym The comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin in NMIBC patients
Scientific Title A prospective randomized study of the comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin for non muscle invasive bladder cancer with intermediate recurrent risk
Scientific Title:Acronym The comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin in NMIBC patients
Region
Japan

Condition
Condition Bladder Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The safety of adjuvant intravesical chemotherapy using pirarubicin compared to the intravessical BCG therapy in NMIBC patients with intermediate recurrent risk
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of adverse effects
Key secondary outcomes 2 Year recurrent 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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravesical instillation of 80mg BCG , weekly, 6times
Intravesical instillation of 30mg pirarubicin, weekly, 8 times
Interventions/Control_2 The patients were examined by cystoscopy and urine cytological examination every 3 months for 2yeras after intravesical instillationto determine bladder tumor recurrence and every 6 months thereafter. The adverse effects were estimated by CTCAE.
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.Histologically confirmed urothelial carcinoma
2. Confirmed NMIBC with intermediate recurrent risk
3.Performance status 0-2
4. Patients able to be assessed, e.g., by cystoscopy and urinary cytology, on a regular basis
5. Male or female, aged 20-90 years
6. Patient that given written informed consent prior to the start of this study
Key exclusion criteria 1.Active double cancer (including upper urinary tract carcinoma and prostate carcinoma)
2. CIS, High grade or MIBC confirmed TURBT
3. Previously received BCG intravesical chemotherapy or intravesical chemotherapy within 1 year
4. Serious drug hypersensitivity
5. Active tuberculosis defined by T spot
6. Severe dysfuction of main organs, CHF with NYHA III or IV, asparates aminotransferase and alanine amonotransferase below 3 times as normal values, Hb A1c >= 8.0%
7. Serious viral and bacterial infection
8. Patients the investigators considered to be inappropriate for this study
Target sample size 116

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshi Naya
Organization Kyoto Prefectural University of Medicine/Meiji University of Integrative Medicine
Division name Urology
Zip code
Address 465 kajiicho, kamigyo-ku, Kyoto
TEL 0752515595
Email ynaya@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Naya
Organization Kyoto Prefectural University of Medicine
Division name Urology
Zip code
Address 465 Kajiicho, kamigyo-ku, Kyoto
TEL 0752515595
Homepage URL
Email ynaya@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Department of Urology
Institute
Department

Funding Source
Organization Self funding
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
2016 Year 09 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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
2016 Year 04 Month 30 Day
Last modified on
2016 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025528

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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