UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of the hearing disorder in the patient receiving cisplatin
Title of the study (Brief title)	Cisplatin hearing disorder study
Region	Japan

Condition
Condition	Malignant tumor
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To observe appearance time, frequency, degree of the hearing disorder receiving high dose cisplatin
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of hearing disorder more than CTCAE Grade2
Key secondary outcomes	Toxicity, dose intensity of cisplatin, change of the mean hearing threshold level

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	Medicine
Interventions/Control_1	To give high dose cisplatin
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 and Female
Key inclusion criteria	1) Malignant tumor patient who will give more than 60 mg/m2 cisplatin 2) The patient who is evaluable in standard pure tone audiometry 3) Adult patient aged over 20 years 4) The patient that a document agreement by the free will after having received enough explanation on participating of this study
Key exclusion criteria	1) The patient that periodical audiometry is impossible 2) Patient younger than 20 years 3) The patient who judged a study doctor to be inappropriate as a subject
Target sample size	100

Research contact person
Name of lead principal investigator	Hideaki Okada
Organization	Kobe minimally invasive cancer center
Division name	Medical oncology
Address	8-5-1, Minatojimanakamachi, Chuo-ku, Kobe-shi, Hyogo
TEL	078-304-4100
Email	shumei_oka@joy.ocn.ne.jp

Public contact
Name of contact person	Hideaki Okada
Organization	Kobe minimally invasive cancer center
Division name	Medical oncology
Address	8-5-1, Minatojimanakamachi, Chuo-ku, Kobe-shi, Hyogo
TEL	078-304-4100
Homepage URL
Email	shumei_oka@joy.ocn.ne.jp

Sponsor
Institute	Kobe minimally invasive cancer center
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 20 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020848