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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010331
Receipt No. 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

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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
Email 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
Email yokoa@uro.med.kyushu-u.ac.jp

Sponsor
Institute Department of Urology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011919

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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