UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000372 |
|---|---|
| Receipt number | R000000355 |
| Scientific Title | Randomized controlled study of TACE therapy for HCC comparing epi-ADM and CDDP |
| Date of disclosure of the study information | 2006/05/31 |
| Last modified on | 2010/04/01 11:01:27 |
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Basic information
Public title
Randomized controlled study of TACE therapy for HCC comparing epi-ADM and CDDP
Acronym
Comparative study between Cis-TACE and Epi-TACE against hepatocellular carcinoma in combination with Lipiodol
Scientific Title
Randomized controlled study of TACE therapy for HCC comparing epi-ADM and CDDP
Scientific Title:Acronym
Comparative study between Cis-TACE and Epi-TACE against hepatocellular carcinoma in combination with Lipiodol
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare efficacy and safety between transcatheter arterial chemical embolization of Epirubicin with Lipiodol and transcatheter arterial chemical embolization of CDDP with Lipiodol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Anti-tumor activity (Response rate = CR+PR).
Response will be evaluated mainly according to the EASL (European Association for the Study of the Liver) guideline. .
Secondarily it will be evaluated according to the Criteria for the Evaluation of Direct Effects of Hepatocellular Carcinoma (2004) and RESIST.
Key secondary outcomes
Survival rate and local-relapse-free survival/QOL survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Make Cisplatin-Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion.
Interventions/Control_2
Dissolve Epirubicin in a contrast medium and then mix with Lipiodol, and infuse it into hepatic artery, followed by Gelpart infusion.
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)A patient who has non-resectable hepatocellular carcinoma confirmed histologically and clinically, and is not suitable for the local treatment.
2)A patient who has the localized measurable disease site without metastasis (in principle a patient should have no embolized main portal vein, no marked A-V shunt and A-P shunt caused by tumor, but even though such conditions are detected if a clinical investigator decides that the patient is suitable for this study this principle is not applied).
3)A patient who does not have previous treatment (in principle 2-week interval should be taken in case of 5-FU, UFT, 5'-DFUR, FUDR etc. or 4-week interval should be taken in case of the other anti-cancer drugs such as CDDP, MTX, DXR, EPI, MMC, ETP and radiation therapy). When there is no influence caused by pretreatment, details will not be asked about the pretreatment.
4)Performance Status(P.S.):0-2
5)Child-Pugh:A or B
6)The functions of main organs (bone marrow, kidney, heart) should be maintained sufficiently and the clinical laboratory test results should fulfill the following conditions of the standard.
Leukocytes:≥3000/mm3,Platelets:≥50000/mm3,Hemoglobin:≥9.5g/dl,Creatinine:≤upper limit of normal value of our institute,BUN:≤25mg/dl,PT:≥50%,Total bilirubin:<2
The above mentioned clinical laboratory tests should be performed 2 weeks before the registration.
7)Sex:regardless of sex
8)Age:not lower than 20 years old and below 80 years old
9)A patients whose life expectancy is more than 2 months and in principle who can be in a hospital during the observation period.
Key exclusion criteria
1)A patient who has severe complications (however chronic hepatitis and liver cirrhosis are excluded for this criteria).
2)A patient who has active double cancers (besides HCC, the double cancers which can decide the prognosis).
3)A patient who has a medical history of severe hyperesthesia.
4)A patient who is pregnant, a nursing mother or is suspected of being pregnant.
5)A patient who is decided by the principal investigator or a clinical investigator not to be an adequate subject for this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetsugu Saito |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 160-8582 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Tada |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 160-8582 Japan
TEL
03-3353-1211
Homepage URL
stada@sc.itc.keio.ac.jp
Sponsor or person
Institute
Department of Internal Medicine
Keio University School of Medicine
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
| 2006 | Year | 05 | Month | 31 | 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
| 2005 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | 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
| 2006 | Year | 03 | Month | 27 | Day |
Last modified on
| 2010 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000355
