UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002222 |
|---|---|
| Receipt number | 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 15:33:50 |
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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
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
ytomita@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Urology Faculty of Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002672
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
