Unique ID issued by UMIN | UMIN000032901 |
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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 |
The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
The investigation of safety and efficacy of short hydration GC therapy
The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
The investigation of safety and efficacy of short hydration GC therapy
Japan |
advanced or metastatic urothelial carcinoma patients
Urology |
Malignancy
NO
To estimate the efficacy and safety of short hydration GC therapy using QOL questionnare and wearable device.
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
adverse events
physiological items
CBC
blood examination
serum CRP level
renal function ex, eGFR
response rate
secondary adverse events
QOL estimation
activity estimated by Fitbits
Observational
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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
10
1st name | |
Middle name | |
Last name | Taku Naiki |
Nagoya City University Graduate School of Medical Sciences
Department of Nephro-urology
kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
052-853-8266
naiki@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Taku Naiki |
Nagoya City University Graduate School of Medical Sciences
Department of Nephro-urology
kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
052-853-8266
http://www.med.nagoya-cu.ac.jp/uro.dir/
naiki@med.nagoya-cu.ac.jp
Nagoya City University Graduate School of Medical Sciences
none
Self funding
NO
2018 | Year | 06 | Month | 20 | Day |
Unpublished
Open public recruiting
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 03 | Month | 10 | Day |
2020 | Year | 04 | Month | 15 | Day |
2020 | Year | 04 | Month | 15 | Day |
2022 | Year | 04 | Month | 15 | Day |
2022 | Year | 04 | Month | 15 | Day |
none
2018 | Year | 06 | Month | 07 | Day |
2018 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037514
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