Unique ID issued by UMIN | UMIN000021298 |
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Receipt number | R000024564 |
Scientific Title | A phase 2 trial of GN (gemcitabine + nedaplatin) therapy for advanced urothelial cancer patients with pre-treatment of cisplatin or carboplatin. |
Date of disclosure of the study information | 2016/03/04 |
Last modified on | 2016/03/02 20:07:39 |
A phase 2 trial of GN (gemcitabine + nedaplatin) therapy for advanced urothelial cancer patients with pre-treatment of cisplatin or carboplatin.
GN for UC with pre-platinum-based-drug-treatment
A phase 2 trial of GN (gemcitabine + nedaplatin) therapy for advanced urothelial cancer patients with pre-treatment of cisplatin or carboplatin.
GN for UC with pre-platinum-based-drug-treatment
Japan |
urothelial cancer
Hematology and clinical oncology | Urology |
Malignancy
NO
To assess the efficacy of GN (gemcitabine + nedaplatin) therapy for urothelial cancer patients who have prior cisplatin or carboplatin treatment
Efficacy
Confirmatory
Pragmatic
Phase II
response rate
adverse event, disease control rate, progression free survival, overall survival, quality of life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
intravenous drip of gemcitabine and nedaplatin
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients histologically confirmed urothelial cancer
2)Patinets with prior treatment of cisplatin or carboplatin
3)Patients with informed consent
1) Patients with sever bone marrow suppression
2) Patinets with interstitial pneumonitis or lung fibrosis
3) Patients with prior radiotherapy for chest
4) Patients with hypersensitivity reaction for the protocol drugs
5) Patients without histological diagnosis
6) Patients with prior therapy used nedaplatin
7) Patients without lesions assessed by RECISTv1.1
62
1st name | |
Middle name | |
Last name | Norihiko Tsuchiya |
Yamagata University
Department of Urology
2-2-2 Iida-Nishi, Yamagata-shi, Yamagta
023-628-5368
norihiko.tsuchiya@gmail.com
1st name | |
Middle name | |
Last name | Sei Naito |
Yamagata University
Department of Urology
2-2-2 Iida-Nishi, Yamagata-shi, Yamagta
023-628-5368
seinaitoh@yahoo.co.jp
Yamagata University, Department of Urology
none
Self funding
NO
山形大学(山形県)
2016 | Year | 03 | Month | 04 | Day |
Unpublished
Preinitiation
2016 | Year | 02 | Month | 15 | Day |
2016 | Year | 03 | Month | 04 | Day |
2016 | Year | 03 | Month | 02 | Day |
2016 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024564
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