UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025305 |
|---|---|
| Receipt number | 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 | 2021/01/07 17:14:47 |
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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 | Keishi |
| Middle name | |
| Last name | Kajikawa |
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
kajikawa@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
hasimoto@aichi-med-u.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029110
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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