UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
Title of the study (Brief title)	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	Taku Naiki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Address	kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL	052-853-8266
Email	naiki@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Taku Naiki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Address	kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL	052-853-8266
Homepage URL	http://www.med.nagoya-cu.ac.jp/uro.dir/
Email	naiki@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037514