UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Yasuyoshi Miyata
Organization	Nagasaki University Hospital
Division name	Urology and Renal Transplantation
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	Yasuyoshi Miyata
Organization	Nagasaki University Hospital
Division name	Urology and Renal Transplantation
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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