Unique ID issued by UMIN | UMIN000009016 |
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Receipt number | R000010581 |
Scientific Title | Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer. |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2016/04/01 18:13:50 |
Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.
Effect of palonosetron in patient receiving chemotherapy including cisplatin for gastric cancer.
Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.
Effect of palonosetron in patient receiving chemotherapy including cisplatin for gastric cancer.
Japan |
Advanced gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To investigate the efficacy and safety of palonosetron for prevention of nausea and emesis in patients receiving chemotherapy involving cisplatin for gastric cancer.
Safety,Efficacy
Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr after chemotherapy, acute phase; 0-24hr, delayed phase; 24-120hr].
1) ratio of patient without emesis.
2) ratio of patient without rescue treatment.
3) ratio of patient without nausea.
4) time to first emesis.
5) evaluation of volume of meal intake.
6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)patients receiving first course of chemotherapy containing cisplatin for gastric cancer.
2) aged 20 years or more.
3) patents had undergone treatment with high emetic risk and moderate emetic risk chemotherapy prior to this study
4) written informed consent from the patients.
1) patients with serious hepatic insufficiency or renal failure.
2) patients with emesis within 24 hours before first administrating of cisplatin.
3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin.
4) patients with emetic factor except for chemotherapy
5) patient who was intended radiation therapy
6) patients judged inappropriate for this study by physicians.
7) patients who received Pimozide.
75
1st name | |
Middle name | |
Last name | Sachio Fushida |
Digestive Disease Support Organization (DDSO)
Gastroenterologic surgery
35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
076-265-2000
oya-ma@staff.kanazawa-u.ac.jp
1st name | |
Middle name | |
Last name | Katsunobu Oyama |
Digestive Disease Support Organization (DDSO)
Gastroenterologic surgery
35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
076-265-2000
oya-ma@staff.kanazawa-u.ac.jp
Digestive Disease Support Organization (DDSO)
Digestive Disease Support Organization (DDSO)
Other
NO
2012 | Year | 10 | Month | 01 | Day |
Unpublished
Complete response rate: 91.6%
Complete protectionrate: 66.7%
Completed
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 10 | Month | 01 | Day |
2014 | Year | 07 | Month | 25 | Day |
2014 | Year | 07 | Month | 25 | Day |
2014 | Year | 07 | Month | 25 | Day |
2015 | Year | 01 | Month | 31 | Day |
To investigate the efficacy and safety of palonosetron for prevention of nausea and emesis in patients receiving chemotherapy involving cisplatin for gastric cancer.
2012 | Year | 10 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010581
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