Unique ID issued by UMIN | UMIN000038747 |
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Receipt number | R000044174 |
Scientific Title | Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer |
Date of disclosure of the study information | 2019/12/01 |
Last modified on | 2020/06/20 21:01:49 |
Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Japan |
Urothelial carcinoma
Urology |
Malignancy
NO
Investigate effects of immunotherapy on oncological and patient reported outcomes inpatients with urothelial cancer
Safety,Efficacy
Effects of immunotherapy on oncological outcomes inpatients with urothelial cancer
Effects of immunotherapy on patient reported outcomes inpatients with urothelial cancer
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Treatment group: Patients received immunotherapy for UC
Control group: Standard chemotherapy: Patients received either gemcitabine 800 mg/m2 on days 1, 8, and 15 plus cisplatin 70 mg/m2 (GCis) on day 2 every 3 wk, or gemcitabine 800 mg/m2 on days 1, 8, and 15 plus carboplatin (GCb) at an area under the curve of 4 according to the Calvert formula on day 2 every 3 wk, for two to four cycles. GCarbo is selected based on renal function (eGFR <60 mL/min/1.73m2) or presence of frailty.
20 | years-old | <= |
100 | years-old | > |
Male and Female
Urothelial cancer who need systemic therapy or immunotherapy
History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to therapy and QoL
200
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki Univ.
Urology
036-8562
Hirosaki
+81172395091
shingorilla2@gmail.com
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki Univ.
Urology
036-8164
5 zaifu-chou, Hirosaki Japan
0172-39-5091
shingoh@hirosaki-u.ac.jp
Hirosaki Univ.
Hirosaki Univ.
Other
Hirosaki University Graduate School of Medicine
5 Zaifu-chou
0172-33-5111
rinri@hirosaki-u.ac.jp
NO
2019 | Year | 12 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 11 | Month | 30 | Day |
2019 | Year | 12 | Month | 01 | Day |
2024 | Year | 12 | Month | 30 | Day |
2019 | Year | 11 | Month | 30 | Day |
2020 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044174
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