UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032901 |
|---|---|
| Receipt number | R000037514 |
| Scientific Title | The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2018/06/07 10:52:44 |
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Basic information
Public title
The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
Acronym
The investigation of safety and efficacy of short hydration GC therapy
Scientific Title
The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
Scientific Title:Acronym
The investigation of safety and efficacy of short hydration GC therapy
Region
| Japan |
Condition
Condition
advanced or metastatic urothelial carcinoma patients
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy and safety of short hydration GC therapy using QOL questionnare and wearable device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
adverse events
Key secondary outcomes
physiological items
CBC
blood examination
serum CRP level
renal function ex, eGFR
response rate
secondary adverse events
QOL estimation
activity estimated by Fitbits
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. urothelial carcinoma patients diagnosed by histology
2. Stage3-4, Stage2 ly+ v+ bladder cancer patients and T4 or N+, M+ upper urinary tract cancer patients.
3. patients aged 20-80 yrs
4. life expectancy is more than 3 mos
5. ECOG-PS 0-2 patients.
6. WBC > 4000, neutrophil > 2000, Hb >9, Platlet > 100000, T-bilirubin < 1.5, AST < 66, ALT < 54, creatinine < 1.7 in male, < 1.1 in female.
Key exclusion criteria
1. patients who had allergy in gemcitabine
2. patients who had allergy in cisplatin
3. previously treated patients by gemcitabine, or cisplatin
4. patients who had sign of interstitial pneumoniae or pulmonary fibrosis
5. patients previously treated in chest by radiation therapy
6. patients who have infection or fever
7. pregnant patients
8. patients giving lactation
9. patients including severe diseases
10. unadequate patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Naiki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Nephro-urology
Zip code
Address
kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL
052-853-8266
naiki@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Naiki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Nephro-urology
Zip code
Address
kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL
052-853-8266
Homepage URL
http://www.med.nagoya-cu.ac.jp/uro.dir/
naiki@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
Address
Tel
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 | 06 | Month | 20 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 15 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037514
