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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024162
Receipt No. 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

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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
Email 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
Email int.doc.miya@m3.dion.ne.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027822

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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