UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005229 |
|---|---|
| Receipt number | R000006217 |
| Scientific Title | PhaseII study of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma -Compared with retrospective historical cohort study with epirubicin hydrochloride- |
| Date of disclosure of the study information | 2011/03/11 |
| Last modified on | 2016/02/03 16:52:23 |
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Basic information
Public title
PhaseII study of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma
-Compared with retrospective historical cohort study with epirubicin hydrochloride-
Acronym
PhaseII study of TACE with miriplatin for HCC
Scientific Title
PhaseII study of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma
-Compared with retrospective historical cohort study with epirubicin hydrochloride-
Scientific Title:Acronym
PhaseII study of TACE with miriplatin for HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of trancatheter arterial chemoembolizaion (TACE) with miriplatin for hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year local disease-free survival rate
Key secondary outcomes
Adverse event
Disease-free survival
Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TACE with miriplatin
Interventions/Control_2
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) Patients with hepatocellular carcinoma that are histologically or clinically confirmed
2) Patients with plethoric lesion that show arterial phase enhancement with dynamic computed tomography or magnetic resonance imaging
3) Patients are unsuitable for resection, transplant, or local ablation therapy
4) Hepatic lesions of therapeutic target exit in only 1 segment or 3 subsegments in the liver
5) Total tumor diameter is less than 6cm
6) Patients who have not received previous treatment for HCC more than 4 weeks ago, have no effects of previous treatment
7) No tumor thrombus in the main trunk and left and right branch of the portal vein
8) Chile Pugh class A or B
9) Organ (bone marrow, heart and kidney)function is maintained fully, patients who fulfill of the inclusion criteria below before registration within 2 weeks
WBC, more than 3000
PLT, more than 5 x 104
AST, less than 5 x the upper limit of the normal range
ALT, less than 5 x the upper limit of the normal range
Total serum Bilirubin, less than 3.0
Serum Creatinine, less than 1.5
Electrocardiography, Patients who have no abnormality to require treatment
10) Performance status score of 2 or less
11) Age more than 20 years old
12) Patients are expected to survive more than 3 months
13) Patients obtained written informed consent
Key exclusion criteria
1) Patients who have medical history of hypersensitivity of platinum-containing drug.
2) Patients who have medical history of hypersensitivity of iodine containing agent and/or contrast material.
3) Extrahepatic metastasis.
4) Bile duct invasion or vascular invasion.
5) Patients after HCC is ruptured.
6) Patients who have medical history of surgical reconstruction of the biliary tract or endoscopic biliary treatment.
7) Patients who have moderate or severe pleural effusion or ascites to be unresponsive to therapy.
8) Severe arterioportal shunt or arteriovenous shunt in the liver.
9) Patients with following severe complicating disease.
- Patients who are difficult to control heart failure, angina or arrhythmia despite treatment
- Cardiac infarction within 6 months of onset
- Renal failure
- Active infections(except viral hepatitis)
- Active gastrointestinal bleeding
- Active duplicative cancer
- Hepatic encephalopathy or severe mental illness
10) Patients who are pregnant, lactating or are suspected to be pregnant.
11) Patients who are concluded to be inappropriate to participate in this study safety by their physicians.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Nishiofuku |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-29-8900
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Nishiofuku |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-29-8900
Homepage URL
hmn@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University, Department of Radiology
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
奈良県立医科大学附属病院（奈良県）
Nara Medical University (Nara prefecture)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | 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
| 2011 | Year | 03 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006217
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