UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004523 |
|---|---|
| Receipt number | R000005392 |
| Scientific Title | Combination Therapy of RFA and Miriplatine Versus RFA for HCC larger than 3cm |
| Date of disclosure of the study information | 2010/11/09 |
| Last modified on | 2013/11/11 16:09:01 |
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Basic information
Public title
Combination Therapy of RFA and Miriplatine Versus RFA for HCC larger than 3cm
Acronym
Combination Therapy of RFA and Miriplatine Versus RFA
Scientific Title
Combination Therapy of RFA and Miriplatine Versus RFA for HCC larger than 3cm
Scientific Title:Acronym
Combination Therapy of RFA and Miriplatine Versus RFA
Region
| Japan |
Condition
Condition
HCC larger than 3cm
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The therapeutic effects of combination therapy of hepatic artery infusion and RFA for HCC larger than 3cm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local recurrence and prognosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy of RFA with hepatic arterial infusion group
Interventions/Control_2
RFA-alone group
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
I.Patients with primary hepatocellular carcinoma diagnosed by
clinical or histological(angiography, CT, etc.) study
II.Hepatocellular carcinoma larger than 3cm, technically possible for radiofrequency ablation (except cases of liver resection), aim to complete cure or mass reduction
III.Organ function is maintained. The following clinical and laboratory criteria must be satisfied.
- Child-Pugh classification A or B patients
- Degree of liver failure (Liver damage) A or B patients
- Platelet count: more than 30,000 / mm3
IV.Patients are expected to survive more than three months from start of treatment at least
V.General conditions ECOG (Japan Clinical Oncology Group) Performance Status 0,1, or 2
VI.Patients obtained writtten informed consent
Key exclusion criteria
I.Patients who are considered not to participate in the study by physicians
II.Patients with moderate or severe infections
III.Patients with uncontrolled diabetes or obstruction
IV.Pregnancy, nursing, or woman who may become pregnant
V.Patients with a history of hypersensitivity to drugs or contrast agents containing iodine
VI.Patients with a history of myocardial infarction within 3 month
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Iwai |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatotlogy
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3811
s-iwai@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Iwai |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatotlogy
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3811
Homepage URL
s-iwai@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city University Graduate School of Medicine
Department of Hepatotlogy
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Department of Hepatotlogy
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
| 2010 | Year | 11 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | 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
| 2010 | Year | 11 | Month | 09 | Day |
Last modified on
| 2013 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005392
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
