UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002401 |
|---|---|
| Receipt number | R000002928 |
| Scientific Title | A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2022/08/10 10:38:27 |
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Basic information
Public title
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Acronym
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Scientific Title
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Scientific Title:Acronym
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 5-FU arterial infusion and interferon thearpy (FAIT) in comparison with sorafenib in patients with advanced hepatocellular carcinoma which is not eligible for or refractory to surgical or locoregional therapies, or transcatheter hepatic arterial chemoembolization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Response rate, progression-free survival, response in tumor markers, incidence and severity of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Experimental arm
5-FU arterial infusion and interferon therapy (FAIT)
Interventions/Control_2
Reference arm
Sorafenib
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with hepatocellular carcinoma which was diagnosed pathologically or by typical radiological findings on enhanced CT or MRI within 4 weeks before registration.
2) Patients with hepatocellular carcinoma which is not eligible for surgical and percutaneous locoregional therapies and is refractory to other conventional therapies such as transcatheter hepatic arterial chemoembolization, with and without portal vein tumor thrombus.
3) Patients with no extrahepatic metastases. In paticular, metastases to the brain should be ruled out on CT or MRI in suspected patients.
4) Patients who has not received any treatment for hepatocellular carcinoma in the last 4 weeks before registration.
5) Patients aged 20-79 years.
6) Patients with Eastern Cooperative Oncology Group Performans Status of 0 or 1.
7) Patients with adequate hematological, hepatic and renal function, as indicated by
Hemoglobin concentration of 8.0g/dl or more
White blood cell count between 3000 and 12000 /mm3
Platelet count of 40000/mm3 or more
Child-Pugh classification A
Serum creatinine concentration of 1.5 mg/dl or less
8) Patients without severe cardiac, pulmonary or psychiatric comorbidities.
9) Patients without any other malignant disease, or with malignancy at least 5 years after curative treatment.
10) Patients agreeing to use adequate contraception methods during the trial.
11) Women who are not pregnant or lactating, and not expecting future pregnancy.
12) Patients who are judged adequate to participate by the atending physician.
Key exclusion criteria
See inclusion criteria.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuntaro Obi |
Organization
Kyoundo Hospital
Division name
Department of Hepatology
Zip code
Address
1-8 kanda-surugadai, Chiyoda-Ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Kondo |
Organization
University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
ykon-tky@umin.ac.jp
Sponsor or person
Institute
Department of Hepatology, Kyoundo Hospital
Institute
Department
Personal name
Funding Source
Organization
Sasaki fundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2009 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2009 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002928
