UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026404 |
|---|---|
| Receipt number | R000030335 |
| Scientific Title | Efficacy and safety of transarterial chemoembolization + vitamin K combination treatment against hepatocellular carcinoma-Open label, randomized, phase 2 study |
| Date of disclosure of the study information | 2017/03/09 |
| Last modified on | 2023/03/17 11:05:34 |
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Basic information
Public title
Efficacy and safety of transarterial chemoembolization + vitamin K combination treatment against hepatocellular carcinoma-Open label, randomized, phase 2 study
Acronym
TACE + vitamin K treatment
Scientific Title
Efficacy and safety of transarterial chemoembolization + vitamin K combination treatment against hepatocellular carcinoma-Open label, randomized, phase 2 study
Scientific Title:Acronym
TACE + vitamin K treatment
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy of transarterial chemoembolization + vitamin K dosing against hepatocellular carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Treatment effect 4 weeks after transarterial chemoembolization
Key secondary outcomes
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
daily dosing of vitamin K2(45mg) since one day before the transarterial chemoembolization to 28 days after
Interventions/Control_2
transarterial chemoembolization without vitamin K dosing
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients indicated to transarterial chemoembolization against hepatocellular carcinoma, ECOG PS 0 or 1, Child-Pugh score 5-7, obtained written informed consent
Key exclusion criteria
Patients who underwent previous transarterial chemoenmbolization greater than twice, patients with warfarin dosing, patients who have been given vitamin K before the enrollment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka General Medical Center
Division name
Department of Laboratory Medicine
Zip code
558-8558
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka, Japan
TEL
+81666921201
apple-123-grape@ab.auone-net.jp
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka General Medical Center
Division name
Department of Laboratory Medicine
Zip code
558-8558
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka, Japan
TEL
+81666921201
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka General Medical Center
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
Osaka General Medical Center
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka, Japan
Tel
+81666921201
kenkyu@gh.opho.jp
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
| 2017 | Year | 03 | 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
101
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
| 2017 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030335
