UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005090 |
|---|---|
| Receipt number | R000005341 |
| Scientific Title | First line Therapy by Sorafenib for Lung Metastases Patients in Renal Cell Carcinoma |
| Date of disclosure of the study information | 2011/02/17 |
| Last modified on | 2015/09/15 15:25:16 |
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Basic information
Public title
First line Therapy by Sorafenib for Lung Metastases Patients in Renal Cell Carcinoma
Acronym
First line Therapy by Sorafenib for Lung Metastases Patients in Renal Cell Carcinoma
Scientific Title
First line Therapy by Sorafenib for Lung Metastases Patients in Renal Cell Carcinoma
Scientific Title:Acronym
First line Therapy by Sorafenib for Lung Metastases Patients in Renal Cell Carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the trial is to study the efficacy of sorafenib therapy in patients with lung metastases renal cell carcinoma who have no history of cytokine therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease Control Rate(CR+PR+SD)
Key secondary outcomes
Response Rate(CR+PR),Progression Free Survival(PFS),Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sorafenib will be given by daily oral administration of 400 mg twice a day
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) Age: At least 20 years of age
2) Patients with ECOG PS 0 or 1
3) Patients who have only lung metastases and confirmed including clear cell renal cell carcinoma
4) Patients who have already nephrectomy
5) Patients with no previous history of cytokine therapy, chemotherapy, or molecularly targeted drug therapy
6) Patients who are expected to survive at least 12 weeks
Key exclusion criteria
1) Patients who have or have had thromboembolism and/or ischemic cardiac disease
2) Poorly controlled hypertension
3) Patients with serious hepatic function disorder
4) Patients who have or have had interstitial pulmonary disease
5) Pregnant or nursing patients
6) Patients being treated with other drugs for purpose of anti cancer treatment
7) Patients who may otherwise compromise subject safety in the conduct of the trial or who may compromise protocol compliance
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe University Graduate school of Medicine
Division name
Department of Urology
Zip code
Address
7-5-1,Kusunoki-tyo,Kobe-city, Japan
TEL
078-382-6155
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyake |
Organization
Kobe University Graduate school of Medicine
Division name
Department of Urology
Zip code
Address
7-5-1,Kusunoki-tyo,Kobe-city, Japan
TEL
078-382-6155
Homepage URL
hmiyake@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
兵庫県 / Hyogo-ken
東京都 / Tokyo-to
和歌山県 / Wakayama-ken
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 15 | Day |
Last modified on
| 2015 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005341
