UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003389 |
|---|---|
| Receipt number | R000004114 |
| Scientific Title | The effect of interferon and tyrosine kinase inhibitor sequential therapy for advanced renal cell carcinoma |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2011/04/02 10:44:18 |
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Basic information
Public title
The effect of interferon and tyrosine kinase inhibitor sequential therapy for advanced renal cell carcinoma
Acronym
Sequential therapy for RCC
Scientific Title
The effect of interferon and tyrosine kinase inhibitor sequential therapy for advanced renal cell carcinoma
Scientific Title:Acronym
Sequential therapy for RCC
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of sequential therapy prior interferon to TKI for the objective responce of renal cell carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who were diagnosed advanced renal cell carcinoma (defined as cancer that has spread outside the kidney).
2)Patients who need not only additional therapy but also surgery.
Key exclusion criteria
1) No severe complications
2) Performance status :Eastern cooperative oncology group>=2 or Karnofsky>=80%
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeaki Yokoi |
Organization
Gifu university hospital
Division name
Urology
Zip code
Address
Yanagido 1-1, Gifu city, Gifu, 501-1194
TEL
058-230-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu university hospital
Division name
Urology
Zip code
Address
Yanagido 1-1, Gifu city, Gifu, 501-1194
TEL
Homepage URL
Sponsor or person
Institute
Gifu university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 04 | Month | 01 | 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
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The effect of interferon or TKI therapy for quality of life.
Management information
Registered date
| 2010 | Year | 03 | Month | 27 | Day |
Last modified on
| 2011 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004114
