UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011785 |
|---|---|
| Receipt number | R000013762 |
| Scientific Title | Phase II randomized controlled trial of epirubicin hydrochloride and miriplatin hydrate as anticancer agents for transcatheter arterial chemoembolization of hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2013/09/17 22:06:15 |
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Basic information
Public title
Phase II randomized controlled trial of epirubicin hydrochloride and miriplatin
hydrate as anticancer agents for transcatheter arterial
chemoembolization of hepatocellular carcinoma
Acronym
NHO-TGMC-2013-02 (HCC-Epirubicin &Miriplatin-P-II)
Scientific Title
Phase II randomized controlled trial of epirubicin hydrochloride and miriplatin
hydrate as anticancer agents for transcatheter arterial
chemoembolization of hepatocellular carcinoma
Scientific Title:Acronym
NHO-TGMC-2013-02 (HCC-Epirubicin &Miriplatin-P-II)
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the local control effects of transcatheter arterial chemoembolization
(TACE) using epirubicin with lipiodol and miriplatin with lipiodol for hepatocellular carcinoma, not indicated ressection nor ablation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
frequency of adverse events, changes of tumor markers, overall survival, one year survival rate, progression free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
transcatheter arterial
chemoembolization for hepatocellular carcinoma by epirubicin
Interventions/Control_2
transcatheter arterial
chemoembolization for hepatocellular carcinoma by miriplatin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or clinically diagnosed hepatocellular carcinoma (HCC).
2) No previous history of TACE by epirubicin or miriplatin
3) No previous history of treatment with anticancer agents (neither by systemic nor arterial infusion)
4) No tyreatment effect expected by locoregional treatment.
5) Advanced HCC (BCLC stage-B or C).
6) Child-Pugh A or B.
7) Age of 20 years or more.
8) ECOG Performance Status of 0 or 1 or 2.
9) Existence of mesurable lesion by modified RECIST.
10) No major organ failure and all the laboratory data, below are conserved.
11) At least 3 months survival expected.
12) Written informed consent obtained from the patient.
Key exclusion criteria
1) Drug allergy by miriplatin or epirubicin.
2) Extrahepatic metastasis.
3) Portal venous invasion in the major trunk or first order branch.
4) Remarkable arterio-portal or arterio-venous shunting.
5) Hepatic artery occlusion.
6) Biliary reconstruction.
7) Comorbid diseases
*Cardiac failure
*Renal failure
*Active infection
*Active gastrointestinal bleeding
*Active associated cancers
*Hepatic encephalopathy
*Refractory ascites or pleural effusion
8) Fever (more than 38 degrees Celsius)
9) Allergy to contrast media
10) Pregnant or lactating
11) Other reasons not indicated to this study judged by doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Naganuma |
Organization
Takasaki General Medical Center, National Hospital Organization
Division name
Department of Gastroenterology
Zip code
Address
36 Takamatsu-machi, Takasaki city, Gunma, Japan
TEL
027-322-5901
numackey@pa2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Toma |
Organization
Takasaki General Medical Center, National Hospital Organization
Division name
Clinical Research Department
Zip code
Address
36 Takamatsu-machi, Takasaki city, Gunma, Japan
TEL
027-322-5901
Homepage URL
tcr-jimu3@takasaki-hosp.jp
Sponsor or person
Institute
Takasaki General Medical Center, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Takasaki General Medical Center, National Hospital Organization
Organization
Division
Category of Funding Organization
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
国立病院機構高崎総合医療センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 17 | Day |
Last modified on
| 2013 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013762
| 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 |
