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

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

Bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

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

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name