UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013016 |
|---|---|
| Receipt number | R000015195 |
| Scientific Title | Prospective study of efficacy and safety of preoperative transcatheter arterial chemolipiodolization with miriplatin for hepatocellular carcinoma.(Phase II study) |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2014/01/30 14:45:47 |
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Basic information
Public title
Prospective study of efficacy and safety of preoperative transcatheter arterial chemolipiodolization with miriplatin for hepatocellular carcinoma.(Phase II study)
Acronym
Phase II trial of preoperative Chemolipiodolization with miriplatin for hepatocellular carcinoma.
Scientific Title
Prospective study of efficacy and safety of preoperative transcatheter arterial chemolipiodolization with miriplatin for hepatocellular carcinoma.(Phase II study)
Scientific Title:Acronym
Phase II trial of preoperative Chemolipiodolization with miriplatin for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of preoperative transcatheter arterial chemolipiodolization with miriplatin for hepatocellular carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
recurrence rate
Key secondary outcomes
Time to recurrence
Tumor marker assessment
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
YES
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transcatheter arterial chemolipiodolization with miriplatin
Interventions/Control_2
Transcatheter arterial infusion with lipiodol
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) Age over 20 years old.
2) Written informed consent
3) The tumor number <= 3 nodules in the liver. The maximum tumor diameter without limit.
4) Adequate organ function for 2 weeks before transcatheter arterial infusion.
Key exclusion criteria
1) Patients who have medical history of hypersensitivity of platinum-containing drug, iodine-containing drug and gelatine.
2) Patients with serious complications(Severe thyroid disease, Severe heart disease and the like.)
3) Patients with active double cancer.
4) Patients with bile duct invasion.
5) Pregnant and lactating females; males and females of childbearing age unless using effective contraception.
6) Patients without remarkable findings of A-V shunt and/or A-P shunt.
7) Tumor thrombosis in main portal vein or vena cava
8) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Kubota |
Organization
Dokkyo Medical University
Division name
Second department of surgery
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282-86-1111
xx@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Kato |
Organization
Dokkyo Medical University
Division name
Second department of surgery
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282-86-1111
Homepage URL
katomasa@dokkyomed.ac.jp
Sponsor or person
Institute
Second department of surgery, Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Second department of surgery, Dokkyo Medical University
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
| 2014 | Year | 01 | Month | 30 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 30 | 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
| 2014 | Year | 01 | Month | 30 | Day |
Last modified on
| 2014 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015195
