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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000364
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kinki University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000465

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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