Unique ID issued by UMIN | C000000256 |
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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 |
Multi-institute randomized study of natural type interferon alpha for patients with renal cell carcinoma after radical nephrectomy
Trial of RCC adjuvant interferon alpha (TRAIn-Alpha)
Multi-institute randomized study of natural type interferon alpha for patients with renal cell carcinoma after radical nephrectomy
Trial of RCC adjuvant interferon alpha (TRAIn-Alpha)
Japan |
Renal cell carcinoma
Urology |
Malignancy
NO
To compare adjuvant natural type interferon with observation after radical nephrectomy
Efficacy
Local recurrence and distant metastasis
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Administration of natural type interferon alpha for at least one year
Observation
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
Active synchronous malignancy
Bellini duct carcinoma
von Hippel-Lindau disease
History of allergy for interferon or vaccine
540
1st name | |
Middle name | |
Last name | Seiji Nito MD |
Kyushu University
Department of Urology
Fukuoka
1st name | |
Middle name | |
Last name | Hideyuki Akaza MD |
University of Tsukuba
Department of Urology
029-853-3223
TRAIn-Alpha study group
The Kidney Foundation, Japan
Non profit foundation
Japan
NO
2005 | Year | 09 | Month | 30 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/22068465
Completed
2001 | Year | 04 | Month | 16 | Day |
2001 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2005 | Year | 09 | Month | 30 | Day |
2012 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000320
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