UMIN-CTR Clinical Trial

Basic information
Public title	Multi-institute randomized study of natural type interferon alpha for patients with renal cell carcinoma after radical nephrectomy
Acronym	Trial of RCC adjuvant interferon alpha (TRAIn-Alpha)
Scientific Title	Multi-institute randomized study of natural type interferon alpha for patients with renal cell carcinoma after radical nephrectomy
Scientific Title:Acronym	Trial of RCC adjuvant interferon alpha (TRAIn-Alpha)
Region	Japan

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

Objectives
Narrative objectives1	To compare adjuvant natural type interferon with observation after radical nephrectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Local recurrence and distant metastasis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of natural type interferon alpha for at least one year
Interventions/Control_2	Observation
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	Pathologically confirmed RCC After radical nephrectomy Stage II or III Performance Status 0 to 2 WBC count 3500 or over PLT count 100000 or over AST, ALT within 2.5 times of institute reference level Creatinine 2.0mg/dl or less Total bilirubin within 1.5 times of institute reference level Written informed consented No prior chemotherapy nor immuno- therapy
Key exclusion criteria	Active synchronous malignancy Bellini duct carcinoma von Hippel-Lindau disease History of allergy for interferon or vaccine
Target sample size	540

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiji Nito MD
Organization	Kyushu University
Division name	Department of Urology
Zip code
Address	Fukuoka
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Hideyuki Akaza MD
Organization	University of Tsukuba
Division name	Department of Urology
Zip code
Address
TEL	029-853-3223
Homepage URL
Email

Sponsor
Institute	TRAIn-Alpha study group
Institute
Department

Funding Source
Organization	The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2005 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/22068465
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	2001 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date	2001 Year 08 Month 01 Day
Last follow-up date	2011 Year 08 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	2005 Year 09 Month 30 Day
Last modified on	2012 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000320

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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