UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of theraputic effects for advanced renal cell carcinoma patients using axitinib; dose intensity, gene polymorphism and micro vascular density
Acronym	The evaluation of theraputic effects for advanced renal cell carcinoma patients using axitinib
Scientific Title	The evaluation of theraputic effects for advanced renal cell carcinoma patients using axitinib; dose intensity, gene polymorphism and micro vascular density
Scientific Title:Acronym	The evaluation of theraputic effects for advanced renal cell carcinoma patients using axitinib
Region	Japan

Condition
Condition	Advanced Renal Cell Carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To measurment dose intensity using axitinib, gene polymorphism and micro vascular density with axitinib
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	dose intensity, gene polymorphism and micro vascular density with axitinib
Key secondary outcomes	clinical response using RECIST ver4.0, adverse event using CTCAE ver4.0, mapping in pathology

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	Gene
Interventions/Control_1	measrument dose intensity using axitinib and measurment gene polymorphism
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) over 20yrs 2) advanced RCC patients (cTxN1-2M0-1) need general treatment 3) ECOG PS0,1 4) suitable organ function liver,kidney, hematolgy 5) noemal herat function LVEF >70% 6) Pts had target lesions difiend vy RECIST ver1.1 7) Pts had informed and concent
Key exclusion criteria	unfit eligible criteria 1)ptotein uria 2+< 2)Pts had another cancers 3)Pts had myocardial infarction, pulumonary embolisim, brain infarction, heart failure, TIA, CABG within 6 months 4) pregnant
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoto Sassa
Organization	Nagoya University
Division name	Urology
Zip code
Address	Showa-ku Tsurumai-Cho 65, Nagoya , Aichi
TEL	052-744-2985
Email	sassa@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Koyama
Organization	Nagoya University
Division name	soumu-ka
Zip code
Address	Showa-ku Tsurumai-Cho 65, Nagoya , Aichi
TEL	052-744-1901
Homepage URL
Email	ethics@med.nagoya-u.ac.jp

Sponsor
Institute	The department of urology, Graduate School of Medicine, Nagoya University
Institute
Department

Funding Source
Organization	The department of urology, Graduate School of Medicine, Nagoya University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 01 Month 22 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
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	Open public recruiting
Date of protocol fixation	2013 Year 01 Month 22 Day
Date of IRB	2013 Year 01 Month 22 Day
Anticipated trial start date	2013 Year 01 Month 23 Day
Last follow-up date	2021 Year 01 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	2013 Year 01 Month 22 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011011