UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy for day 1 administration of gemcitabine and cisplatin
Title of the study (Brief title)	Safety and efficacy for day 1 administration of gemcitabine and cisplatin
Region	Japan

Condition
Condition	Urothelial carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy for day 1 administration of gemcitabine and cisplatin
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	gemcitabine and cisplatin
Interventions/Control_2
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	urothelial carcinoma
Key exclusion criteria	nothing
Target sample size	20

Research contact person
Name of lead principal investigator	Takeshi Azuma
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Urology
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo , Japan
TEL	042-323-5111
Email	tazuma-tky@umin.a.cjp

Public contact
Name of contact person	Takeshi Azuma
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Urology
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo , Japan
TEL	042-323-5111
Homepage URL
Email	tazuma-tky@umin.ac.jp

Sponsor
Institute	Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization	Local Government
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	2018 Year 01 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 01 Month 25 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	2018 Year 01 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035397