Unique ID issued by UMIN | UMIN000008110 |
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Receipt number | R000009544 |
Scientific Title | Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE) |
Date of disclosure of the study information | 2012/06/05 |
Last modified on | 2015/12/05 11:55:27 |
Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE)
Antiemetic therapy in germ cell tumor
Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE)
Antiemetic therapy in germ cell tumor
Japan |
Germ cell tumor
Hematology and clinical oncology | Urology |
Malignancy
NO
Efficacy
Safety
Complete response
Conplete control (no emetic episodes, no rescue medication use and no more than mild nausea), adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Aprepitant, palonosetron and dexamethasone
20 | years-old | <= |
Not applicable |
Male
1. Germ cell tumor
2. Receiving BLM/ETP/CDDP chemotherapy
3. No history of systemic chemotherapy
4. Sufficient organ functions
5. Ability of oral intake
6. ECOG PS 0-2
7. Informed consent
1. Uncontrollable complications
2. Brain metastasis
3. Active convulsive disease
4. Plural effusion or ascites requiring puncture
5. Obstruction of the gastric outlet or ileus
6. Vomiting or severe nausea before the chemotherapy
7. Anaphylaxis against 5-HT3 receptor inhibitors, aprepitant or dexamethasone
8. Disapproval of contraception
9. History og aprepitant or palonostron
10. Participation of other clinical trials of antiemetics
30
1st name | |
Middle name | |
Last name | Fumimasa Fukuta |
Sapporo Medical University School of Medicine
Department of Urology
South 1 West 16, Chuo-ku, Sapporo, Japan
81-11-611-2111
ffukuta@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Fumimasa Fukuta |
Sapporo Medical University School of Medicine
Department of Urology
South 1 West 16, Chuo-ku, Sapporo, Japan
81-11-611-2111
uroikai@sapmed.ac.jp
Department of Urology, Sapporo Medical University School of Medicine
Department of Urology, Sapporo Medical University School of Medicine
Other
NO
札幌医科大学附属病院(北海道)、旭川赤十字病院(北海道)、帯広協会病院(北海道)、砂川市立病院(北海道)、NTT東日本札幌病院(北海道)、王子総合病院(北海道)、函館五稜郭病院(北海道)、製鉄記念室蘭病院(北海道)
2012 | Year | 06 | Month | 05 | Day |
Unpublished
Open public recruiting
2012 | Year | 04 | Month | 09 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 05 | Day |
2015 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009544
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