UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001153 |
|---|---|
| Receipt number | 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 16:26:07 |
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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
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
ykobaya@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graguate School of Medicine, Dentistry and Pharmaceutical Sciences.
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001399
