UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009833 |
|---|---|
| Receipt number | R000011011 |
| Scientific Title | The evaluation of theraputic effects for advanced renal cell carcinoma patients using axitinib; dose intensity, gene polymorphism and micro vascular density |
| Date of disclosure of the study information | 2013/01/22 |
| Last modified on | 2021/01/28 16:37:23 |
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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
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
ethics@med.nagoya-u.ac.jp
Sponsor or person
Institute
The department of urology, Graduate School of Medicine, Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011011
