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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025305
Receipt No. R000029110
Scientific Title Usefulness of short hydration GC therapy for urothelial carcinoma
Date of disclosure of the study information 2016/12/25
Last modified on 2019/05/08

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Basic information
Public title Usefulness of short hydration GC therapy for urothelial carcinoma
Acronym Usefulness of short hydration GC therapy for urothelial carcinoma
Scientific Title Usefulness of short hydration GC therapy for urothelial carcinoma
Scientific Title:Acronym Usefulness of short hydration GC therapy for urothelial carcinoma
Region
Japan

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

Objectives
Narrative objectives1 To assess the clinical safety and the usefulness of short hydration GC thrapy for urothelial carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in estimation glomerular filtration rate between before and after the course
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 On the first day of 28days, cisplatin(CDDP) 70mg/m2 and gemcitabine(GEM) 1000mg/m2 are intravenously infused, with about 1L of drinking water and a total of about 2L of fluid replacement by the end of CDDP administration. On day 8 and 15, GEM 1000mg/m2 is intravenous infuse.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Urothelial carcinoma
2)WBC>=3,000/x10^(-6)L,PLT>=10,000/x10^(-6)L,Hb>=10g/dL,Ccr>=60mL/min
3)sufficient understanding of drinking water instruction has been made
4)Cardiac function is retained
5)Performance Status 0-1
6)With no serious complications
7)Patient consent is obtained

Key exclusion criteria 1)There is a sever kidney dysfunction(Ccr<60mL/min)
2)WBC<3,000/x10^(-6)L, PLT<10,000/x10^(-6)L
3)Evident in the chest X-ray, and has a interstitial pneumonitis or pulmonary fibrosis of clinical symptoms
4)Underwent radiation therapy to the chest
5)Merged with serious infections
6)Women suspected of being pregnant or pregnant
7)Patients with hypersensitivity to the drug to use and the drug including the platinum
8)Patients attending physician has determined ineligible in the practice of this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masahito
Middle name
Last name Watanabe
Organization Aichi Medical University Hospital
Division name Urology
Zip code 4801195
Address 1-1 Yazako karimata Nagakute City Aichi Prifecture Zip:480-1195
TEL 0561-62-3311
Email watanabe.masahito.738@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Toshifumi
Middle name
Last name Hashimoto
Organization Aichi Medical University Hospital
Division name Administration Division
Zip code 4801195
Address 1-1 Yazako karimata Nagakute City Aichi Prifecture Zip:480-1195
TEL 0561-62-3311
Homepage URL
Email hasimoto@aichi-med-u.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization None
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 Aichi Medical University Hospital
Address 1-1 Yazako karimata Nagakute City Aichi Prifecture Zip:480-1195
Tel 0561-62-3311
Email hasimoto@aichi-med-u.ac.jp

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 12 Month 25 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 03 Day
Date of IRB
2016 Year 10 Month 03 Day
Anticipated trial start date
2016 Year 10 Month 03 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 16 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029110

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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