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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005229
Receipt No. 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

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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
Email

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
Email hmn@naramed-u.ac.jp

Sponsor
Institute Nara Medical University, Department of Radiology
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006217

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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