UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000256
Receipt number R000000320
Scientific Title Multi-institute randomized study of natural type interferon alpha for patients with renal cell carcinoma after radical nephrectomy
Date of disclosure of the study information 2005/09/30
Last modified on 2012/05/25 10:50:28

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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 or person

Institute

TRAIn-Alpha study group

Institute

Department

Personal name



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

Value
https://center6.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