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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004067
Receipt No. R000004879
Scientific Title Phase II Clinical Study of Interferon+Sorafenib Combination Therapy in Advanced Renal Cell Carcinoma
Date of disclosure of the study information 2010/09/01
Last modified on 2010/08/18

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Basic information
Public title Phase II Clinical Study of Interferon+Sorafenib Combination Therapy in Advanced Renal Cell Carcinoma
Acronym IFN+Sorafenib Combination Therapy for Advanced RCC
Scientific Title Phase II Clinical Study of Interferon+Sorafenib Combination Therapy in Advanced Renal Cell Carcinoma
Scientific Title:Acronym IFN+Sorafenib Combination Therapy for Advanced RCC
Region
Japan

Condition
Condition Advanced renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The effect and safety of sequential therapy prior interferon to IFN+sorafenib combination therapy for the objective responce of renal cell carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Objective response
Key secondary outcomes Safety

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 interferon-alpha administration

sorafenib administration
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1.Age: 20 <=, 75 >
2.Patients with ECOG PS 0, 1 or 2
3.Histologically confirmed renal cell carcinoma
4.Patients with metastasis(M)+ or lymph node(N)+
5.Patients with nephrectomy
6.Patients with no previous history of cytokine therapy, or molecularly targeted therapy.6) patients with at least 1 measurable lesion on CT, as defined by RECIST
7.Patients who are expected to survive at least 3 months
8.Patients who meet 1) through 9) of the following test and adequate functions of major organs
1) hemoglobin >= 9.0 g/dL
2) neutrophil count >= 1,500/microL
3) platelet>=100,000//microL
4) PT or PT-INR and APTT <= 1.5 times the maximum of the normal range of each institute
5) total bilirubin <= 1.5 times the maximum of the normal range of each institute
6) ALT and AST <= 2.5 times the maximum of the normal range of each institute
( <= 5 times the maximum of the normal range at the study site in patients with hepatic metastasis)
7) alkali phosphatase <= 4 times the maximum of the normal range of each institute
8) serum creatinine <= 2.0 times the maximum of the normal range of each institute
9) amylases and lipases <=2.0 times the maximum of the normal range of each institute
9. Patients with written, signed, dated, and witnessed informed consent prior to the study
Key exclusion criteria 1.Patinets being treated with Shosaikoto
2.Patients with autoimmunehepatitis
3.Known hypersensitivity to interferon or Sorafenib
4.Known hypersensitivity to biologics, such as vaccines
5.Myocardial infarction within the previous 12 months
6.Severe arrhythmias
7.Active or symptomatic angina pectoris or coronary artery disease
8.Poorly controlled hypertension
9.Previous history of renal failure
10.Poorly controlled diabetes mellitus
11.Active acute or chronic infection or serious intercurrent illness
12.Liver cirrhosis
13.Intracranial metastasis
14.Interstitial pulmonary disease
15.Severe mental disorder, such as severe depression
16.Pregnant, or women who have a possibility of pregnancy
17.Investigator determines as unsuitable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Kadono
Organization Kanazawa University School of Medicine
Division name Department of Urology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2393
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University School of Medicine
Division name Department of Urology
Zip code
Address
TEL 076-265-2393
Homepage URL
Email

Sponsor
Institute Hokuriku Advanced Renal cell carcinoma Study Group
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Open public recruiting
Date of protocol fixation
2010 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 08 Month 18 Day
Last modified on
2010 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004879

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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