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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030160
Receipt No. R000033426
Scientific Title The influence of GC therapy on QOL for metastatic and recurrent invasive urothelial carcinoma
Date of disclosure of the study information 2018/01/01
Last modified on 2017/11/28

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Basic information
Public title The influence of GC therapy on QOL for metastatic and recurrent invasive urothelial carcinoma
Acronym The influence of GC therapy on QOL for invasive urothelial carcinoma
Scientific Title The influence of GC therapy on QOL for metastatic and recurrent invasive urothelial carcinoma
Scientific Title:Acronym The influence of GC therapy on QOL for invasive urothelial carcinoma
Region
Japan

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

Objectives
Narrative objectives1 To investigate the changes in QOL by GC (gemcitabine and cisplatin) therapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes QOL
Key secondary outcomes Adverse events
Anti-cancer effect

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine is administarrated 3 times for 3 weeks. Cisplatine is administrated 1 time.
This is 1 cycle and we undergo 3 cycles. So, time of administration is 3 months.
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The patients with metastatic or recurrent invasive urothelial carcinoma who are able to receive GC therapy
Key exclusion criteria The patients who are not able to receive GC therapy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Kikuchi
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tkyo, Japan
TEL 03-5363-3825
Email eiji-k@kb3.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Kikuchi
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3825
Homepage URL
Email eiji-k@kb3.so-net.ne.jp

Sponsor
Institute Keio University School of Medicine
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
2018 Year 01 Month 01 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
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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
2017 Year 11 Month 28 Day
Last modified on
2017 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033426

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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