UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022153 |
|---|---|
| Receipt number | 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 16:42:13 |
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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
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
ynaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Department of Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025528
