UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024162 |
|---|---|
| Receipt number | R000027822 |
| Scientific Title | Comparison between intravesical BCG therapy and intravesical BCG and MMC therapy for prevention of recurence and treatment of in situ cancer in non-muscle invasive bladder cancer patients with intermediate or high risk disease. |
| Date of disclosure of the study information | 2016/09/27 |
| Last modified on | 2016/09/26 10:45:53 |
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Basic information
Public title
Comparison between intravesical BCG therapy and intravesical BCG and MMC therapy for prevention of recurence and treatment of in situ cancer in non-muscle invasive bladder cancer patients with intermediate or high risk disease.
Acronym
Comparison between intravesical BCG and BCG+MMC therapy for prevention of recurence and treatment of in situ cancer in intermediate or high risk non-muscle invasive bladder cancer.
Scientific Title
Comparison between intravesical BCG therapy and intravesical BCG and MMC therapy for prevention of recurence and treatment of in situ cancer in non-muscle invasive bladder cancer patients with intermediate or high risk disease.
Scientific Title:Acronym
Comparison between intravesical BCG and BCG+MMC therapy for prevention of recurence and treatment of in situ cancer in intermediate or high risk non-muscle invasive bladder cancer.
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy for prevention of urinary tract recurrence on intravesical BCG therapy and intravesical BCG+MMC therapy in non-muscle invasive bladder cancer with intermediate or high risk disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary tract recurrence-free survival periods.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
BCG=80mg was performed once a week for 8 times and then once a month for 9 times.
Interventions/Control_2
BCG=80mg and MMC=40mg were performed once a week for 8 times and then once a month for 9 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who match followed all items;
1: Non-muscle invasive bladder cancer with high grade urothelial carcinoma.
2: No metastasis of lymph node and distant organ by any imaging examinations.
3: Radical cystectomy is difficult or no hope of this operation.
4: Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0-1.
5: Blood examinations fulfill followed data.
White blood cells: >3,000/mm3,
Neutrophil: >1,500 /mm3,
Platelet: >100,000 /mm3,
Hemoglobin: >8 g/dl,
AST and ALT: <3 times of upper limited value,
Total bilirubin: <1.5 mg/dl,
Serum creatinine: <2.0 mg/dl,
Fating blood sugar: <125 mg/dl
Key exclusion criteria
1: The chance of living over 6 months
2: With active tuberculosis
3: Allergy for BCG or MMC
4: With other maligancy or has plan of treatment for the disease.
5: The doctor judged as improper.
Target sample size
284
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Miyata |
Organization
Nagasaki University Hospital
Division name
Urology and Renal Transplantation
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7340
int.doc.miya@m3.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Miyata |
Organization
Nagasaki University Hospital
Division name
Urology and Renal Transplantation
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7340
Homepage URL
int.doc.miya@m3.dion.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
| 2016 | Year | 09 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2016 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027822
