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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000372
Receipt No. 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

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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:&#8805;3000/mm3,Platelets:&#8805;50000/mm3,Hemoglobin:&#8805;9.5g/dl,Creatinine:&#8804;upper limit of normal value of our institute,BUN:&#8804;25mg/dl,PT:&#8805;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
Email

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
Email stada@sc.itc.keio.ac.jp

Sponsor
Institute Department of Internal Medicine
Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000355

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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