Unique ID issued by UMIN | UMIN000010957 |
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Receipt number | R000012822 |
Scientific Title | Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer. |
Date of disclosure of the study information | 2013/06/16 |
Last modified on | 2016/09/26 10:48:49 |
Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer.
Efficacy and safety of combination therapy of low dose gemcitabine and paclitaxeltherapy with sorafenib in patients with cisplatin-resistant urothelial cancer.
Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer.
Efficacy and safety of combination therapy of low dose gemcitabine and paclitaxeltherapy with sorafenib in patients with cisplatin-resistant urothelial cancer.
Japan |
Cisplatin-resistant urothelial cancer
Hematology and clinical oncology | Urology |
Malignancy
NO
To clarify safety.
Efficacy
Frequency of adverse events.
Overall survival.
Quality of life.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gemcitabine (700 mg/m2): Day 1.
Paclitaxel (70 mg/m2): Day 1.
Sorafenib (400mg/day) Day 8 - 21.
repeated every 28 days as long as possible.
20 | years-old | <= |
Not applicable |
Male and Female
CDDP-resistance.
Advanced disease.
Blood examinations
WBC: under 3,000 / mm3.
Neut: under 1,500 / mm3.
Plt: under 100,000/ mm3.
Hgb: under 8 g/dl.
T-Bil: over 1.5 mg/dl.
s-Cr: over 2.0 mg/dl.
15
1st name | |
Middle name | |
Last name | Hideki Sakai |
Nagasaki University Hospital
Urology
1-7-1 Sakamoto, Nagasaki
095-819-7340
hsakai@nagasaki-u.ac.jp
1st name | |
Middle name | |
Last name | Yasuyoshi Miyata |
Nagasaki University Hospital
Urology
1-7-1 Sakamoto
095-819-7340
int.doc.miya@m3.dion.ne.jp
Nagasaki University Hospital
Urology in Nagasaki University
Self funding
NO
2013 | Year | 06 | Month | 16 | Day |
Published
Completed
2013 | Year | 03 | Month | 05 | Day |
2013 | Year | 03 | Month | 05 | Day |
2013 | Year | 06 | Month | 13 | Day |
2016 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012822
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