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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002222
Receipt No. R000002672
Scientific Title Phase II clinical trial of interleukin-2, interferon-alpha and tegafur uracil therapy for advanced renal cell cancer
Date of disclosure of the study information 2009/07/21
Last modified on 2016/03/31

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Basic information
Public title Phase II clinical trial of interleukin-2, interferon-alpha and tegafur uracil therapy for advanced renal cell cancer
Acronym IATRCC
Scientific Title Phase II clinical trial of interleukin-2, interferon-alpha and tegafur uracil therapy for advanced renal cell cancer
Scientific Title:Acronym IATRCC
Region
Japan

Condition
Condition advanced renal cell cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of IL-2+IFN-alpha+tegafur uracil (IAT) therapy for advanced renal cell cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes anti-tumor response
Key secondary outcomes Time to progression, duration of response, overall survival, servival at home, performance status

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 Interleulin-2, inteferon-alpha, tegafur uracil
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)PS 0,1 or 2.
(2)MSKCC risk classification; favorable or intermediate.
(3)Histological confirmed renal cell carcinoma. Not includes sarcomatoid RCC as a major component.
(4)Patients with pulmonary metastasis only, but includes those with no appearance of new lesion 4 weeks after surgical resection of extra-pulmonary metastasis.
(5)No ischemic heart disease
(6)Laboratory evaluation
1)Respiratory function; %VC >=80%, FEV1.0 >=70%
2)WBC>=4,000/mm2, platelet>=10,000/mm2
3)AST, ALT within normal range of each institute. total bil.<1.5mg/dl serum creatinine<2.0mg/dl, BUN<25mg/dl
Key exclusion criteria (1)uncontrolled DM
(2)ischemic heart disease
(3)allergic reaction to IL-2 and/or IFN-alpha
(4)auto-immune disease
(5)patients having Shou-Sai-Kotou (special herbal drug) and/or steroids
(6)depression
(7)Investigator determines as unsuitable
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Tomita
Organization Yamagata University
Division name Department of Urology Faculty of Medicine
Zip code
Address Iida-nishi 2-2-2 Yamagata
TEL 023-628-5368
Email ytomita@med.id.yamagata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Tomita
Organization Yamagata University Hospital
Division name Department of Urology
Zip code
Address Iida-nishi 2-2-2 Yamagata
TEL 023-628-5368
Homepage URL
Email ytomita@med.id.yamagata-u.ac.jp

Sponsor
Institute Department of Urology Faculty of Medicine
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 宮城県立がんセンター(宮城県)、獨協医科大学病院(栃木県)、東京慈恵会医科大学附属病院(東京都)、北里大学病院(神奈川県)、新潟大学医歯学総合病院(新潟県)、新潟市民病院(新潟県)、琉球大学医学部付属病院(沖縄県)、

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 21 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
2009 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 18 Day
Last modified on
2016 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002672

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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