UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002928 |
|---|---|
| Receipt number | R000002771 |
| Scientific Title | pilot study of intraarterial 5-fluorouracil/interferon combination therapy for advanced hepatocellular carcinoma patients who do not response to intraarterial 5-fluorouracil/cisplatin combination therapy. |
| Date of disclosure of the study information | 2009/12/22 |
| Last modified on | 2013/07/18 20:19:56 |
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Basic information
Public title
pilot study of intraarterial 5-fluorouracil/interferon combination therapy for advanced hepatocellular carcinoma patients who do not response to intraarterial 5-fluorouracil/cisplatin combination therapy.
Acronym
IFN/5FU for advanced HCC patients who do not response to low dose FP
Scientific Title
pilot study of intraarterial 5-fluorouracil/interferon combination therapy for advanced hepatocellular carcinoma patients who do not response to intraarterial 5-fluorouracil/cisplatin combination therapy.
Scientific Title:Acronym
IFN/5FU for advanced HCC patients who do not response to low dose FP
Region
| Japan |
Condition
Condition
advanced hepatocellular caricinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of intraarterial 5-fluorouracil and interferon combination therapy for advanced hepatocellular carcinoma patients who do not respond to intraarterial 5-fluorouracil and cisplatin combination therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
1) overall survival
2) time to progression
3) safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One course of chemotherapy represented 2 weeks. 5FU (300 mg/m2/24h) was administered using a mechanical infusion pump on days 1-5 of the first and second weeks. Recombinant interferon alfa-2b 3*106 U (3MU) was administered intramuscularly on days 1, 3 and 5 of each week. A 2- to 4-week rest period of no treatment was allowed after each treatment course. Treatment was repeatec unless HCC reveales progressive disease (acording to RECIST).
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of HCC was confirmed histopathologically or clinically.
2) no adaptation of resection, liver transplantation and local abration.
3) no response to low dose FP
4) without uncontrollable ascites
5) without hepatic coma
6) PS 0-1
7) chronic hepatitis or Child-Pugh A or B
8)
WBC > 3000/mm3
Plt > 80000/mm3
Hb > 10.0 g/dl
Total Bilirubin < 2.0 mg/dl
Albumin > 3 g/dl
Creatine < 1.2mg/dl
Prothromin time > 60 percentage
Key exclusion criteria
1) With other malignant disease.
2) A pregnant woman, or a woman suspected of pregnancy.
3) With severe infectious disease.
4) With history of severe allergy.
5) With severe renal function disease. 6) With severe allergy for 5FU or IFN.
7) With severe bone marrow supression.
8) With pulmonary fibrosis.
9) with shosaikoto
10) with autoimmune hepatitis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Hiroshima University
Division name
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University
Division name
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Bio
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
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
| 2009 | Year | 12 | Month | 22 | 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 | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2013 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002771
