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 in metastatic urothelial carcinoma patients - The investigation of safety and efficacy of short hydration GC therapy

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032901

Enrollment

Registered

2018-06-20

Start date

2018-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced or metastatic urothelial carcinoma patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
adverse events	—

Secondary

Measure	Time frame
physiological items CBC blood examination serum CRP level renal function ex, eGFR response rate secondary adverse events QOL estimation activity estimated by Fitbits	—

Countries

Japan

Contacts

Public ContactTaku Naiki

Nagoya City University Graduate School of Medical Sciences Department of Nephro-urology

naiki@med.nagoya-cu.ac.jp052-853-8266

Outcome results