UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005455 |
|---|---|
| Receipt number | R000006368 |
| Scientific Title | Adjuvant InterFeron After Curative Resection of HCV-related Hepatocellular Carcinoma in Elderly Patients: a Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2011/04/20 |
| Last modified on | 2017/03/26 16:53:41 |
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Basic information
Public title
Adjuvant InterFeron After Curative Resection of HCV-related Hepatocellular Carcinoma in Elderly Patients: a Multicenter Randomized Controlled Trial
Acronym
iFACT trial
Scientific Title
Adjuvant InterFeron After Curative Resection of HCV-related Hepatocellular Carcinoma in Elderly Patients: a Multicenter Randomized Controlled Trial
Scientific Title:Acronym
iFACT trial
Region
| Japan |
Condition
Condition
HCV-related hepato cellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate and clarify the efficacy and safety of adjuvant interFeron therapy after curative resection of HCV-related hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Recurence free survival
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant interferon alpha therapy. Three times of 3,000,000 units / a week.
Interventions/Control_2
Close follow-up
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
| 61 | years-old | <= |
Age-upper limit
| 77 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Ages between 61 and 77 years old
2) Primary HCC or recurrent HCC more than two years after previous therapy
3) Classical HCC
4) HCV chronic hepatitis or cirrhosis
5) No extrahepatic lesions
6) Fine or moderate organ function fulfilling the following criteria.
7) Child-Pugh score < 8
8) ECOG performance status 0-2
9) CES-D score <16
10) Written informed consent
Key exclusion criteria
1) Positive HBs-Ag
2) Other anticancer treatment or interferon therapy within 3 months before surgery.
3) Specific drug which is forbidden in this trial is needed.
4) Participating in other clinical trial regarding HCC
5) Autoimmune hepatitis, alcoholic hepatitis, etc.
6) Allergy for specific biologics
7) Severe postoperative complications
8) Asthma
9) Diabetes requiring insulin therapy
10) Severe hypertension
11) Heart disease that complicates perioperative treatments
12) Interstitial pneumonia
13) Psychiatric disorder
14) Malignant disease in other organ within 5 years
15) Moderate or severe renal dysfunction (estimated Ccr < 30ml/min)
16) Other reason that an attending doctor considers
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
kihase-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeaki Ishizawa |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
kihase-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 20 | 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
| 2011 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 17 | Day |
Last modified on
| 2017 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006368
| Research Plan | |
|---|---|
| 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 |
