UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective randomized study of the comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin for non muscle invasive bladder cancer with intermediate recurrent risk
Title of the study (Brief title)	The comparison intravesical BCG therapy with intravesical chemotherapy using pirarubicin in NMIBC patients
Region	Japan

Condition
Condition	Bladder Cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The safety of adjuvant intravesical chemotherapy using pirarubicin compared to the intravessical BCG therapy in NMIBC patients with intermediate recurrent risk
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentage of adverse effects
Key secondary outcomes	2 Year recurrent free rate

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravesical instillation of 80mg BCG , weekly, 6times Intravesical instillation of 30mg pirarubicin, weekly, 8 times
Interventions/Control_2	The patients were examined by cystoscopy and urine cytological examination every 3 months for 2yeras after intravesical instillationto determine bladder tumor recurrence and every 6 months thereafter. The adverse effects were estimated by CTCAE.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histologically confirmed urothelial carcinoma 2. Confirmed NMIBC with intermediate recurrent risk 3.Performance status 0-2 4. Patients able to be assessed, e.g., by cystoscopy and urinary cytology, on a regular basis 5. Male or female, aged 20-90 years 6. Patient that given written informed consent prior to the start of this study
Key exclusion criteria	1.Active double cancer (including upper urinary tract carcinoma and prostate carcinoma) 2. CIS, High grade or MIBC confirmed TURBT 3. Previously received BCG intravesical chemotherapy or intravesical chemotherapy within 1 year 4. Serious drug hypersensitivity 5. Active tuberculosis defined by T spot 6. Severe dysfuction of main organs, CHF with NYHA III or IV, asparates aminotransferase and alanine amonotransferase below 3 times as normal values, Hb A1c >= 8.0% 7. Serious viral and bacterial infection 8. Patients the investigators considered to be inappropriate for this study
Target sample size	116

Research contact person
Name of lead principal investigator	Yoshi Naya
Organization	Kyoto Prefectural University of Medicine/Meiji University of Integrative Medicine
Division name	Urology
Address	465 kajiicho, kamigyo-ku, Kyoto
TEL	0752515595
Email	ynaya@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yoshio Naya
Organization	Kyoto Prefectural University of Medicine
Division name	Urology
Address	465 Kajiicho, kamigyo-ku, Kyoto
TEL	0752515595
Homepage URL
Email	ynaya@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Department of Urology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 30 Day
Anticipated trial start date	2016 Year 09 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 04 Month 30 Day
Last modified on	2016 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025528