UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021981 |
|---|---|
| Receipt number | R000025336 |
| Scientific Title | Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction |
| Date of disclosure of the study information | 2016/04/19 |
| Last modified on | 2017/10/20 13:55:47 |
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Basic information
Public title
Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction
Acronym
Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction
Scientific Title
Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction
Scientific Title:Acronym
Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of sorafenib in patients with Renal cell carcinoma with impaired renal function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR(every 4 weeks)
Key secondary outcomes
overall Survival
Progression Free Survival(PFS)
Response Rate(CR+PR)
Safety
To confirm the molecular target drug usage before and after
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
Administration of sorafenib
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)Histologically proven Renal cell carcinoma
(2)Over 20yrs
(3)PS:0-1(ECOG grade)
(4)eGFR<90ml/min(including dialysis patients)
(5)Surgically unresectable
(6)Life Expectancy must be >=6 months
(7)Adequate hematologic, hepatic and respiratory function
(8)Interval of at least 2 weeks between prior treatment and start of present study
(9)Written informed consent
Key exclusion criteria
(1)Presence or past history of interstitial pneumonia or pulmonary fibrosis or possible
(2)Active infections(excluding viral hepatitis)
(3)Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus
(4)Presence of pleural effusion or ascites requiring drainage
(5)Presence of metastasis in central nerve system
(6)Active double cancer except carcinoma in situ or intramucosal cancer(synchronous double or asynchronous double cancer with disease free duration to be within 3 years)
(7)Pregnant females or nursing mothers who can not stop lactation.Patients or partners, who do not attempt to doing contraception during the study period.
(8)Severe mental disorder
(9)Severe drug hypersensitivity
(10)As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Suzuki |
Organization
Shinshu University school of medicine
Division name
Department of Urology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
+81263372661
yokoso1046@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Suzuki |
Organization
Shinshu University school of medicine
Division name
Department of Urology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
+81263372661
Homepage URL
yokoso1046@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University school of medicine
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 04 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | 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
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2017 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025336
