UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010331 |
|---|---|
| Receipt number | R000011919 |
| Scientific Title | A randomized control study to evaluate the prevention of recurrence and the safety of BCG (Bacillus Calmette-Guerin) instillation therapies between induction alone and induction + low-dose maintenance in non-muscle invasive bladder cancer |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2020/04/06 17:15:11 |
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Basic information
Public title
A randomized control study to evaluate the prevention of recurrence and the safety of BCG (Bacillus Calmette-Guerin) instillation therapies between induction alone and induction + low-dose maintenance in non-muscle invasive bladder cancer
Acronym
A low-dose BCG instillation maintenance therapy in non-muscle invasive bladder cancer
Scientific Title
A randomized control study to evaluate the prevention of recurrence and the safety of BCG (Bacillus Calmette-Guerin) instillation therapies between induction alone and induction + low-dose maintenance in non-muscle invasive bladder cancer
Scientific Title:Acronym
A low-dose BCG instillation maintenance therapy in non-muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
Non-muscle invasive bladder cancer(Ta,T1)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the superiority of recurrence free survival in BCG half-dose maintenance therapy comparing to the BCG induction alone in non-muscle invasive bladder cancer(Ta, T1)after TURBT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Recurrence-free survival
Key secondary outcomes
Progression-free survival
Overall survival
Compliance of protocol treatment
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard dose(80mg)of BCG(Bacillus Calmette-Guerin)instillation induction therapy
Interventions/Control_2
BCG induction(80mg)and low-dose(40mg)maintenance therapy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Complete resection of non-muscle invasive bladder cancer by TURBT
2)Histological diagnosis of urothelial carcinoma.
3)To be fallen into at least one of the following categories.
(first diagnosed)
More than two tumors
(recurrent)
More than two tumors
-History of twice or more treatments for superficial bladder cancer
-History of non-muscle invasive bladder cancer within 12 months
4)ECOG Performance Status is from 0to2
5)20 to 80 years of age,inclusive
6)Normal blood test.to fulfill all requirements(a.-f.)
a.Hb.>=10g/dL
b.platelets>=10*10^4/mm
c.white blood cells>= 3000/mm^3
d.AST,ALT,and ALP:withindoublestandard-value
e.total bilirubin<=2.0mg/dL
f.serum creatinine<=1.5mg/dL
7)Written informed consent
Key exclusion criteria
1)Active tuberculosis or significant positive on PPD test
2)History of CIS
3)History of MIBC(Muscle Invasive Bladder Cancer)
4)History of malignant tumor in upper urinary tract
5)Active multiple primary cancer (including upper urethral cancer or malignant tumor in prostatic urethra)
6)History of BCG instillation
7)Received anti-cancer drug instillation into the bladder within four weeks before TURBT
8)History of intravenous or intra-arterial systemic chemotherapy of anti-cancer drug, or radiation therapy
9)Severe infection disease in urinary tract
10)History of severe bacterial or viral infection within four weeks
11)Immunosuppressive glucocorticoid or other immunosuppressive treatments
12)Immunosuppressive diseases
13)Interstitial pneumonia or pulmonary fibrosis
14)Contracted bladder
15)Severe complications such as cardiovascular disorder, respiratory disease, kidney disease, liver disease or blood disease
16)Other severe diseases
17)History of severe drug allergy
18)Pregnant woman, nursing mother, woman expecting pregnancy
19)Other concerns about BCG therapy (physician's decision)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Naito |
Organization
Harasanshin Hospital
Division name
Department of Urology
Zip code
812-0033
Address
Taihakumachi 1-8, Hakata-ku, Fukuoka, Japan
TEL
092-291-3434
naito@harasanshin.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yokomizo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Urology
Zip code
812-0033
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL
092-642-5603
Homepage URL
yokoa@uro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Institutional Review Board for Clinical Research
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
Tel
092-642-5082
bynintei@jimu.kyushu-u.ac.jp
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
九州大学病院(福岡県) Kyushu University Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 28 | 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
125
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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011919
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| Registered date | File name |
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