UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009622 |
|---|---|
| Receipt number | R000003874 |
| Scientific Title | Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of Japanese patients with metastatic renal cell carcinoma |
| Date of disclosure of the study information | 2012/12/25 |
| Last modified on | 2012/12/25 14:56:07 |
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Basic information
Public title
Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of Japanese patients with metastatic renal cell carcinoma
Acronym
Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of metastatic renal cell carcinoma
Scientific Title
Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of Japanese patients with metastatic renal cell carcinoma
Scientific Title:Acronym
Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of metastatic renal cell carcinoma
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploration of novel biomarkers for response to Sunitinib therapy in the treatment of metastatic renal cell carcinoma in Japanese patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inflammation markers
IL-6, CRP, IL-8, hepcidin
immunologic markers
Th1/Th2 bias, TReg, MDSC
angiogenesis markers
VEGF-C, soluble VEGFR-2, soluble VEGFR-3, b-FGF
Key secondary outcomes
response rate, progression free survival, overall survival, safety
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Japanese patients older than 18.
2.Diagnosed as metastatic renal cell carcinoma with clear cell component.
3.No chemotherapy/radiation has been performed/ or No efficacy by cytokine treatment
4.Having evaluable disease by CT scan, which is regulated in RECIST.
5. Performance status (ECOG) 0-1
6. Maintaining vital organ functions
7. Survival period is expected more than 12 weeks
8. Informed consent has been obtained
Key exclusion criteria
1.brain metastasis
2.uncontrollable hypertention
3.Active or symptomatic angina pectoris or coronary artery disease (myocardial infarction within 12 months or symptomatic unstable angina), Symptomatic congestive heart failure, Long QTc
4.History of being allergic to Sunitinib
5.Pregnant or lactating woman, including the possibility of pregnant
6.Post organ transplantation, including hematopoietic stem cell transplantation
7.History of malignancy, excluding following cases
Cervical cancer (carcinoma in situ), Basal cell carcinoma, Superficial bladder cancer(Ta, Tis and T1, which have been treated properly
Malignancies treated radically more than 3 years before, without recurrence
8.History of VEGF/ VEGF-R targeted therapy
9.Systemic treatment with steroids
10.Interstitial pneumonia
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Oya |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3825
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3825
Homepage URL
mizunor@z7.keio.jp
Sponsor or person
Institute
Tokyo metropolitan Sutent study group
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
慶應義塾大学病院、日本医科大学付属病院、東京慈恵会医科大学付属病院、東京慈恵会医科大学付属柏病院、杏林大学医学部付属病院、東京女子医科大学付属病院、埼玉医科大学付属病院、川崎市立川崎病院、
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in biomarkers for response to Sunitinib therapy
Management information
Registered date
| 2012 | Year | 12 | Month | 25 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003874
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| Registered date | File name |
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