UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008769 |
|---|---|
| Receipt number | R000010307 |
| Scientific Title | Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/11/09 20:23:36 |
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Basic information
Public title
Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma
Acronym
Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma
Scientific Title
Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma
Scientific Title:Acronym
Efficacy and Safety of Everolimus in Patients with Unresectable or 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
To assess the Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free Survival, PFS
Key secondary outcomes
1) Overall survival from the initiation of everolimus treatment 2) ORR 3) TTF 4) Safety profile 5) predictive factors
prognotic factors
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) Patients with unresectable or metastatic renal cell carcinoma who have confirmed histological or cytological diagnosis of clear cell renal cell carcinoma 2) Patients who have at least one measurable foci on CT or MRI 3) 18 years old or older 4) ECOG PS 0-1 5) No interstitial pneumonia on the lungs observed on chest CT
Key exclusion criteria
1) Patients with history of hypersensitivity against everolimus or sirolimus derivative 2) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby 3) Patients judged ineligible to participate in the study by the investigator
Target sample size
120
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 Shinanomachi Shinjuku-ku, Tokyo
TEL
(03)3353-1211
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 Shinanomachi Shinjuku-ku, Tokyo
TEL
(03)3353-1211
Homepage URL
mizunor@z7.keio.jp
Sponsor or person
Institute
Tokyo Afinitor Clinical Trial Group - RCC(TACT-R)
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not started
Management information
Registered date
| 2012 | Year | 08 | Month | 25 | Day |
Last modified on
| 2015 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010307
