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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005090
Receipt No. 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

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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
Email

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
Email hmiyake@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate school of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005341

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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