Unique ID issued by UMIN | UMIN000013415 |
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Receipt number | R000015639 |
Scientific Title | Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma |
Date of disclosure of the study information | 2014/03/24 |
Last modified on | 2024/03/20 19:37:34 |
Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Japan |
postoperative patients with Stage I seminoma
Nephrology | Urology |
Malignancy
NO
To validate the Calvert formula in postoperative Japanese patients with Stage I seminoma.
Pharmacokinetics
Exploratory
Pragmatic
Not applicable
Pharmacokinetics analysis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Blood samples (10 points for 24hours) are collected after the administration of carboplatin for pharmacokinetic analysis.
20 | years-old | <= |
Not applicable |
Male
1) Histologically proven Stage I seminoma patients after sugery
2) Age>=20years
3) Planned to receive carboplatin
4) eGFR>60mL/min
5) ECOG PS:0-1
6)Adequate organ function
white-cell count>= 3,000/uL
platelet count>= 100,000/uL
hemoglobin concentration >= 9.0g/uL
7)Written informed consent
8)Life expectancy more than 3 months
1) Administration of carboplatin is contraindicated
2) Administration of inulin is contraindicated
3)Judged by investigator to be inappropriate for study participation for serious psychiatric condition
4)Judged by investigator to be inappropriate for study participation for any reason
10
1st name | Yuichi |
Middle name | |
Last name | Ando |
Nagoya University Hospital
Clinical Oncology and Chemotherapy
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-1903
yando@med.nagoya-u.ac.jp
1st name | Tomoya |
Middle name | |
Last name | Shimokata |
Nagoya University Hospital
Clinical Oncology and Chemotherapy
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-1903
tshimo@med.nagoya-u.ac.jp
Nagoya University Hospital
None
Other
Nagoya University Certified Review Board
65Tsurumai,Showa,Nagoya
052-744-1901
ethics@med.nagoya-u.ac.jp
NO
2014 | Year | 03 | Month | 24 | Day |
Unpublished
28
No longer recruiting
2013 | Year | 12 | Month | 10 | Day |
2014 | Year | 03 | Month | 24 | Day |
2014 | Year | 03 | Month | 24 | Day |
2024 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 13 | Day |
2024 | Year | 03 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015639
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