UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000842 |
|---|---|
| Receipt number | R000001010 |
| Scientific Title | Randomized Prospective Trial of Intravesical Bacillus Calmette-Guerin Instillation with Low Dose versus Standard Dose for Transitional Cell Carcinoma of the Urinary Bladder |
| Date of disclosure of the study information | 2007/10/05 |
| Last modified on | 2014/04/24 17:51:17 |
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Basic information
Public title
Randomized Prospective Trial of Intravesical Bacillus Calmette-Guerin Instillation with Low Dose versus Standard Dose for Transitional Cell Carcinoma of the Urinary Bladder
Acronym
Low dose BCG study
Scientific Title
Randomized Prospective Trial of Intravesical Bacillus Calmette-Guerin Instillation with Low Dose versus Standard Dose for Transitional Cell Carcinoma of the Urinary Bladder
Scientific Title:Acronym
Low dose BCG study
Region
| Japan |
Condition
Condition
Initial or recurrent superficial bladder cancer that cannot be completely resected and carcinoma in situ (CIS) of the bladder.
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of Immunobladder for intravesical instillation at a dose of 40 mg in superficial bladder cancer that cannot be completely resected and carcinoma in situ (CIS) of the bladder in comparison with Immunobladder for intravesical instillation at a standard dose of 80 mg in a randomized comparative study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate (CR rate)
Key secondary outcomes
1) Relapse-free survival (all secondarily
enrolled subjects/subjects with CR)
2) Incidence of adverse drug reactions
3) Progression-free survival
4) Achievement rate for instillation frequency
5) Overall survival rate
6) QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Freeze-dried BCG for intravesical use (Japanese strain) (Immunobladder for intravesical instillation 80 mg/40 mL) will be instilled 8 times.
Interventions/Control_2
Freeze-dried BCG for intravesical use (Japanese strain) (Immunobladder for intravesical instillation 40 mg/40 mL) will be instilled 8 times.
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) Histologically confirmed transitional cell carcinoma.
2) Confirmed superficial bladder cancer that cannot be completely resected or carcinoma in situ (CIS) of the bladder. CIS may be primary, secondary or concurrent. In patients with concurrent CIS however, coexisting bladder cancer must be only superficial and have been completely resected.
*Note: Patients with concurrent CIS who have received radical TURBT will be excluded from this study although biopsy is required. Patients with concurrent CIS who have had coexisting superficial bladder cancer resected at least twice to complete elimination will be excluded from this study because the start of treatment of concurrent CIS may be complicated.
3) Performance status of 0 to 2.
4) Patients that can receive assessment, such as cystoscopy and urinary cytology on a regular basis.
5) Male or female, aged between 20 and 85 years.
6) Intact function of the main organs
Hb>=10 g/dL; PLT>=10104/mm3; WBC>=3,000/mm3; AST (GOT), ALT (GPT), ALP<normal value2, serum creatinine<=1.5 mg/dL.
7) Patients that have given written informed consent prior to the start of this study.
Key exclusion criteria
1)Active tuberculous lesion or strongly positive tuberculin reaction*.
*: Strongly positive tuberculin reaction is defined as redness with a maximum diameter of >= 10 mm accompanied by induration with redness, blister, and necrosis.
2) Active double cancer (including upper urinary tract carcinoma and prostatic urethral cancer)
3) Previously received BCG intravesical instillation therapy
4) History of upper urinary tract carcinoma
5) Previously received systemic intravenous or intra-arterial infusion of an anti-cancer drug or radiation therapy for bladder cancer
6) Previously received TURBT, systemic chemotherapy or intravesical instillation therapy with an anti-cancer drug within 4 weeks prior to biopsy
7) Contracted bladder
8) Serious drug hypersensitivity
9) Previously received local radiation therapy for the bladder
10) Patients receiving pharmacotherapy, including steroids at an immunosuppressive dose
11) Serious viral or bacterial infection
12) Interstitial pneumonia or pulmonary fibrosis
13) Severe cardiac (circulatory), pulmonary, renal, hepatic, or hematopoietic impairment
14) Other serious complications
15) Pregnant or possibly pregnant women
16) Patients the investigator considers to be inappropriate for this study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Naito |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Urology
Zip code
Address
3-1-1 Maidashi, Higashi-ku Fukuoka 812-8582, Japan
TEL
092-642-5603
naito@uro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yokomizo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Urology
Zip code
Address
3-1-1 Maidashi, Higashi-ku Fukuoka 812-8582, Japan
TEL
092-642-5603
Homepage URL
http://www.evidence.jp/bcg/
yokoa@uro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Study Group for Low-dose BCG Intravesical Instillation Therapy
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2007 | Year | 10 | Month | 05 | 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
Completed
Date of protocol fixation
| 2006 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 04 | Day |
Last modified on
| 2014 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001010
