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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001153
Receipt No. R000001399
Scientific Title Randomized control trial on efficacy of transcatheter arterial chemoembolization with cisplatin-lipiodol suspension or epirubicin-lipiodol emulsion for hepatocellular carcinoma.
Date of disclosure of the study information 2008/05/20
Last modified on 2008/05/13

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Basic information
Public title Randomized control trial on efficacy of transcatheter arterial chemoembolization with cisplatin-lipiodol suspension or epirubicin-lipiodol emulsion for hepatocellular carcinoma.
Acronym Randomized control trial on efficacy of transcatheter arterial chemoembolization for hepatocellular carcinoma.
Scientific Title Randomized control trial on efficacy of transcatheter arterial chemoembolization with cisplatin-lipiodol suspension or epirubicin-lipiodol emulsion for hepatocellular carcinoma.
Scientific Title:Acronym Randomized control trial on efficacy of transcatheter arterial chemoembolization for 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 compare with the efficacy and safety on transcatheter arterial chemoembolization between cisplatin-lipiodol suspension and epirubicin-lipiodol emulsion in patients with hepatocellular carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Response Rate
Key secondary outcomes Overall survival
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CDDP-LPD group : Powdered cisplatin suspended in lipiodol and mixed with a contrast medium is injected through the catheter selectively introduced into the hepatic artery, followed by embolizing with gelatin particles. The doses of suspension are determined according to tumor size, number of tumors and the location of tumor. If the patients treated with TACE do not have complete uptake of lipiodol, they are retreated with TACE at the interval of 3-4 months.
Interventions/Control_2 EPI-LPD group : Epirubicin dissolved in a contrast medium and mixed with lipiodol is injected through the catheter selectively introduced into the hepatic artery, followed by embolizing with gelatin particles. The doses of emulsion are determined according to tumor size, number of tumors and the location of tumor. If the patients treated with TACE do not have complete uptake of lipiodol, they are retreated with TACE at the interval of 3-4 months.
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. Histologically or clinically confirmed hepatocellular carcinoma.
2. Primary cancer, or recurrent cancer that recurred after complete response was obtained by previous treatment with surgical resection, local ablation or TACE.
3. No indication for surgical resection or local ablation.
4. Without extrahepatic metastases.
5. Without tumor thrombosis in portal vein, hepatic vein and bile duct.
6. No massive type or diffuse type tumor
7. Without uncontrolled ascites.
8. Without hepatic encephalopathy.
9. Without marked A-V shunt and A-P shunt.
10. PS is 0 or 1.
11. Child-Pugh is A or B.
12. Sufficient functions of main organ (bone marrow, kidney, heart) and conditions filled the following criteria.
1. WBC >= 3,000/mm3
2. Plt >= 5x104/mm3
3. Hb >= 9.5g/dl
4. T. Bilirubin =< 2.0mg/dl
5. Alb >=2.8g/dl
6. SCr =< upper limit of criteria of each institute.
7. BUN =< 25mg/dl
8. PT >= 50%
13. Age is more than 20 years old and below 80 years old.
14. Life expectancy is more than 3 months.
Key exclusion criteria 1. Active double cancers.
2. Severe complications (excluding chronic hepatitis and liver cirrhosis).
3. Cardiomyopathy , congestive heart failure or medical history of them.
4. Total dose limiting of anticancer drugs with cardiac toxicity, ex. anthracyclin.
5. Medical history of severe hypersensitivity.
6. Pregnant, lactating women or women with suspected pregnancy.
7. Inappropriate patients for this study judged by the physicians.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Yamamoto
Organization Okayama University Graguate School of Medicine, Dentistry and Pharmaceutical Sciences.
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1, Shikata-cho, Okayama-shi, Okayama 700-8558, Japan
TEL 086-235-7219
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Kobayashi
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1, Shikata-cho, Okayama-shi, Okayama 700-8558, Japan
TEL 086-235-7219
Homepage URL
Email ykobaya@md.okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Okayama University Graguate School of Medicine, Dentistry and Pharmaceutical Sciences.
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
2008 Year 05 Month 20 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
Date of protocol fixation
2007 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2015 Year 08 Month 01 Day
Date of closure to data entry
2015 Year 08 Month 01 Day
Date trial data considered complete
2015 Year 08 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 05 Month 12 Day
Last modified on
2008 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001399

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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