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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000292
Receipt No. R000000371
Scientific Title Control Group and Maintenance Treatment with Bacillus Calmette-Guerin for Superficial Bladder Cancer: A Prospective Randomized Trial
Date of disclosure of the study information 2005/12/01
Last modified on 2015/11/30

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Basic information
Public title Control Group and Maintenance Treatment with Bacillus Calmette-Guerin for Superficial Bladder Cancer: A Prospective Randomized Trial
Acronym Bacillus Calmette-Guerin for Superficial Bladder Cancer
Scientific Title Control Group and Maintenance Treatment with Bacillus Calmette-Guerin for Superficial Bladder Cancer: A Prospective Randomized Trial
Scientific Title:Acronym Bacillus Calmette-Guerin for Superficial Bladder Cancer
Region
Japan

Condition
Condition superficial bladder cancer, carcinoma in situ (CIS)
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of maintenance Bacillus Calmette-Guerin therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recurrence-free survival
Key secondary outcomes overall survival, progression rate, complete response rate in CIS

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 not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BCG instilled once a week for 8 weeks
Interventions/Control_2 BCG instilled once a week for 6 weeks, followed by three weekly instillations at month 3, 6, and 12
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) written informed consent. 2) complete resection of superficial bladder cancer within 6 weeks (with or without CIS). 3) histological diagnosis of transitional cell carcinoma. 4) histological diagnosis of superficial bladder cancer(Ta, T1) or carcinoma in situ (CIS). to fulfill at least one of the requirements (a. - e.) a. 3 (or more) separate tumors b. more than 3cm in tumor diameter c. CIS d. history of twice or more treatments for superficial bladder cancer e. history of superficial bladder cancer within 12 months 5) no medical history of BCG treatment within 12 months and no medical history of plural BCG treatments. 6) no medical history of administration of anticancer drugs or antimetabolic drugs within 4 weeks. 7) normal blood test. to fulfill all requirements (a.-f.) a. white blood cells: 3300/mm3-10000/ mm3 b. platelets: more than 10X104/mm3 c. Hb.: more than 9.5g/dl d. AST(GOT) and ALT(GPT): within double standard-value e. total bilirubin: less than 2.0mg/dl f. creatinine: less than1.5mg/dl 8) age 20-79 years 9) Performance Status (PS): 0-2(ECOG)
Key exclusion criteria 1) invasive bladder cancer or history of invasive bladder cancer 2) malignant tumor in upper urinary tract or malignant tumor in urethra 3) lymph node or distant metastasis 4) injection of anticancer drug for bladder cancer. radiation for bladder cancer 5) immunosupressive glucocorticoid or other immunosupressive treatments 6) immunosupressive diseases 7) active malignant diseases except for bladder cancer 8) active tuberculosis or anti tuberculosis therapy 9) severe bacterial urinary tract infection disease or medical history of severe infection within 4 weeks 10) medical history of severe irritation or severe complications such as cardiovascular disorder, respiratory disease, kidney disease, liver disease or blood disease 11) medical history of BCG allergy 12) contracted bladder 13) interstitial pneumonia or pulmonary fibrosis 14) pregnant woman, nursing mother, woman expecting pregnancy 15) other concerns about BCG therapy (physician's decision)
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Mimata, MD, PhD
Organization Faculty of Medicine, Oita University
Division name Department of Urology
Zip code
Address Idaigaoka1-1, Hasama-cho, Yufu-shi, Oita 879-5593, Japan
TEL 097-586-5893
Email mimata@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuminori Sato, MD, PhD
Organization Oita BCG study group
Division name Department of Oncological Science (Urology), Faculty of Medicine, Oita university
Zip code
Address Idaigaoka1-1, Hasama-cho, Yufu-shi, Oita 879-5593, Japan
TEL 097-586-5893
Homepage URL
Email fs@oita-u.ac.jp

Sponsor
Institute Oita BCG study group
Institute
Department

Funding Source
Organization Oita university
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
2005 Year 12 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 No longer recruiting
Date of protocol fixation
2005 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2005 Year 11 Month 30 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000371

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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