UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000364 |
|---|---|
| Receipt number | R000000465 |
| Scientific Title | A randomized study of intravesical BCG therapy for superficial bladder cancer -The comparative study for low doses of BCG treatment- |
| Date of disclosure of the study information | 2006/03/24 |
| Last modified on | 2013/03/27 14:25:56 |
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Basic information
Public title
A randomized study of intravesical BCG therapy for superficial bladder cancer
-The comparative study for low doses of BCG treatment-
Acronym
A clinical study of intravesical BCG therapy
Scientific Title
A randomized study of intravesical BCG therapy for superficial bladder cancer
-The comparative study for low doses of BCG treatment-
Scientific Title:Acronym
A clinical study of intravesical BCG therapy
Region
| Japan |
Condition
Condition
Superficial bladder cancer (Ta or T1, Grade1-2)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate recurrence prevention effect and safety of intravesical BCG-connaught strain (27mg or 13.5mg) treatment following transurethral resection of a bladder tumor (TURBT) in patients with superficial bladder cancer
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
Relation between the incidence of fever (over 37 degrees C) and non-recurrence rate
Adverse drug reactions
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
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: After TURBT, administering 27mg/41mL of BCG-connaught strain intravesically once a week, 6 times in total
Interventions/Control_2
B: After TURBT, administering 13.5mg/40.5mL of BCG-connaught strain intravesically once a week, 6 times in total
Interventions/Control_3
C: TURBT alone
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) Patients aged between 20 and 85 at the time of registration
2) Patients with Performance Status (P.S.) levels of 0 to 2 [ECOG (Zubrod) score]
3) Patients in whose case all the tumors were removed within 1 month before the first day of administration, and the urinary cytology following TURBT was negative for malignancy.
4) Of patients whose all tumors removed by the TURBT this time was histologically confirmed to be superficial transitional-cell cancer, those who satisfy any of the following conditions.
[Primary patients] Stage Ta or T1, G1-2
[Recurrent patients] Stage Ta or T1, G1-2 and the recurrence period between the previous TURBT and the present TURBT was 12 months or longer
5) Patients with no carry-over effects of previous treatments.
6) Patients with sufficient function of the major organs
7) Written informed consent obtained
Key exclusion criteria
Patient who meet one of criteria below are excluded.
1) Patients with carcinoma in situ (CIS)
2) Patients with invasive cancer of the muscle layer of the urinary bladder or a history thereof
3) Patients complicated with malignant tumors of upper urinary tract or urethra, or a history thereof
4) Patients with lymph node metastasis or metastasis in other organs
5) Patients who have received intravenous or intraarterial chemotherapy with anticancer drugs or radiotherapy for bladder carcinoma
6) Patients who have been treated with intravesical BCG
7) Patients currently on medications including steroids at immunosuppressive doses
8) Patients with congenital or acquired immunodeficiency
9) Patients with active double cancers
10) Patients with active tuberculosis or currently receiving anti-tuberculosis therapy
11) Patients with serious bacterial urinary tract infection, or a history of serious viral or bacterial infection within 4 weeks before registration
12) Patients with serious hypersensitivity or other serious complications (diseases of heart, lungs, kidneys, liver or blood)
13) Patients with a history of systemic hypersensitivity against BCG
14) Patients with a strongly positive tuberculin response
15) Patients with contracted bladder
16) Patients with interstitial pneumonia or pulmonary fibrosis
17) Pregnant, possibly pregnant or lactating women
18) Other patients assessed to be ineligible by investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Uemura, MD, PhD |
Organization
Kinki University School of Medicine
Division name
Department of Urology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University School of Medicine
Division name
Department of Urology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL
072-366-0221
Homepage URL
Sponsor or person
Institute
Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2006 | Year | 03 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2005 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 23 | Day |
Last modified on
| 2013 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000465
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