UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004067 |
|---|---|
| Receipt number | 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 | 2023/01/12 21:57:20 |
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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
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
Sponsor or person
Institute
Hokuriku Advanced Renal cell carcinoma Study Group
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004879
