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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000256 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Renal cell carcinoma | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | Active synchronous malignancy
Bellini duct carcinoma von Hippel-Lindau disease History of allergy for interferon or vaccine |
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Target sample size | 540 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | Fukuoka | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | University of Tsukuba | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | |||||||
TEL | 029-853-3223 | ||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |