UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000719 |
|---|---|
| Receipt number | R000000863 |
| Scientific Title | Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study- |
| Date of disclosure of the study information | 2007/05/22 |
| Last modified on | 2019/04/15 21:09:45 |
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Basic information
Public title
Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study-
Acronym
Combination therapy of 5FU/gemcitabine/CDDP for advanced HCC with extrahepatic metastases -A pilot study-
Scientific Title
Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study-
Scientific Title:Acronym
Combination therapy of 5FU/gemcitabine/CDDP for advanced HCC with extrahepatic metastases -A pilot study-
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma with extrahepatic metastases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of the combination therapy of 5FU/gemcitabine/CDDP for advanced hepatocellular carcinoma with extrahepatic metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response for extrahepatic metastases
Key secondary outcomes
Overall survival
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
The combination therapy of 5FU/gemcitabine/CDDP.
Contunue the protocol as long as progression disease is observed.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Unresectable hepatocellular carcinoma with extrahepatic metastases.
Child Pugh A.
Not suitable candidate for S-1 and IFN therapy.
Without ascites.
Without hepatic coma.
Eastern cooperative Oncology Group 0, or 1.
WBC > 2000/mm3
Plt > 100000/mm3
Hb > 10.0g/dl
Total Bilirubin < 2.0mg/dl
Albumin > 2.8g/dl
Creatine < 1.2mg/dl
Prothromin time > 40 percentage
Key exclusion criteria
With other malignant disease.
A pregnant woman, or a woman suspected of pregnancy.
With severe infectious disease.
With history of severe allergy.
With severe renal function disease.
With S-1.
With severe allergy for 5FU, gemcitabine, or CDDP.
With severe bone marrow supression.
With pulmonary fibrosis.
With the history of radiotharpy for lung.
Target sample size
5
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 | Kiminori Uka |
Organization
Hiroshima University
Division name
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Bio
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
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
| 2007 | Year | 05 | 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
Completed
Date of protocol fixation
| 2007 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2007 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2007 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2009 | 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
| 2007 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000863
| 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 |
