Unique ID issued by UMIN | UMIN000026739 |
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Receipt number | R000030694 |
Scientific Title | The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer. |
Date of disclosure of the study information | 2017/04/01 |
Last modified on | 2019/03/08 14:34:21 |
The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer.
Antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting.
The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer.
Antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting.
Japan |
advanced lung cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of aprepitant, 5-HT3 receptor antagonist, dexamethasone, and olanzapine to prevent carboplatin-containing chemotherapy-induced nausea and vomiting.
Safety,Efficacy
Phase II
Complete response rate during the 120 h after carboplatin administration.
Complete response rate during the acute, delayed phase. Complete control rate, safety.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
No need to know
1
Treatment
Medicine |
aprepitant, 5-HT3 receptor antagonist, dexamethasone, olanzapine
20 | years-old | <= |
Not applicable |
Male and Female
1)advanced lung cancer patients who receive carboplatin containing chemotherapy
2)20 years old or older.
3)performance status 0-2.
4)written informed consent.
1)patients with the history of hypersensitivity or allergy for study drugs.
2)patients who need and use antiemetic therapy during 48h before chemotherapy.
3)patients with severe hepatic or renal dysfunction.
4)With convulsion.
5)Patients who need puncture to manage ascites.
6)Patients with complications inducing nausea and vomiting.
7)Patients with diabetes mellitus.
8)Patients who are judged to be inappropriate for this study.
30
1st name | |
Middle name | |
Last name | Takafumi Suda |
Hamamatsu university school of medicine
Second Division, Department of Internal Medicine
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
053-435-2263
suda@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Kazuki Tanaka |
Hamamatsu university school of medicine
Second Division, Department of Internal Medicine
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
053-435-2263
41231644@hama-med.ac.jp
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
None
Self funding
NO
浜松医科大学医学部付属病院(静岡県), 磐田市立総合病院(静岡県), 藤枝市立総合病院(静岡県), 聖隷浜松病院(静岡県), 聖隷三方原病院(静岡県), 静岡県立総合病院(静岡県), 済生会静岡病院(静岡県)
2017 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 01 | Month | 26 | Day |
2017 | Year | 04 | Month | 01 | Day |
2018 | Year | 07 | Month | 19 | Day |
2018 | Year | 10 | Month | 25 | Day |
2018 | Year | 10 | Month | 25 | Day |
2018 | Year | 12 | Month | 25 | Day |
2017 | Year | 03 | Month | 28 | Day |
2019 | Year | 03 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030694
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