UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000292 |
|---|---|
| Receipt number | 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 09:26:13 |
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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
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
fs@oita-u.ac.jp
Sponsor or person
Institute
Oita BCG study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000371
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