UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013415
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

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Basic information

Public title

Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma

Acronym

Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma

Scientific Title

Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma

Scientific Title:Acronym

Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma

Region

Japan


Condition

Condition

postoperative patients with Stage I seminoma

Classification by specialty

Nephrology Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To validate the Calvert formula in postoperative Japanese patients with Stage I seminoma.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Pharmacokinetics analysis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Blood samples (10 points for 24hours) are collected after the administration of carboplatin for pharmacokinetic analysis.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Ando

Organization

Nagoya University Hospital

Division name

Clinical Oncology and Chemotherapy

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-1903

Email

yando@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Tomoya
Middle name
Last name Shimokata

Organization

Nagoya University Hospital

Division name

Clinical Oncology and Chemotherapy

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-1903

Homepage URL


Email

tshimo@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Certified Review Board

Address

65Tsurumai,Showa,Nagoya

Tel

052-744-1901

Email

ethics@med.nagoya-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

28

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2013 Year 12 Month 10 Day

Date of IRB

2014 Year 03 Month 24 Day

Anticipated trial start date

2014 Year 03 Month 24 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 13 Day

Last modified on

2024 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name