UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036081 |
|---|---|
| Receipt number | R000041109 |
| Scientific Title | Prospective comparative study of long-term impact of radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) on liver function in patients with single HCC |
| Date of disclosure of the study information | 2019/03/05 |
| Last modified on | 2024/04/03 11:55:57 |
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Basic information
Public title
Prospective comparative study of long-term impact of radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) on liver function in patients with single HCC
Acronym
RFA versus SBRT for single HCC
Scientific Title
Prospective comparative study of long-term impact of radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) on liver function in patients with single HCC
Scientific Title:Acronym
COMPASS
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
SBRT has been reported to have high local control rate and safety for HCC, but no studies so far have compared SBRT and RFA from the viewpoint of influence on liver function. The purpose of this study is to compare RFA and SBRT in this respect, as well as local control rate, and to clarify the advantages and disadvantages of each treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of ALBI score (comparison between baseline and 3 months after RFA/SBRT)
Key secondary outcomes
Local recurrence free survival
Best treatment effect
Recurrence
Overall survival
Changes of ALBI score (6, 9, and 12months)
Changes of Child-Pugh score (3, 6, 9, and 12 months)
Time to liver function worsening
Adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Single, 3cm or smaller, and no metastasis
Life expectancy of 3 months or longer
Key exclusion criteria
Child-Pugh score of 10 or more
Palliative radiotherapy
Informed consent not obtained
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Central Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
mu13951@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Central Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
Homepage URL
mu13951@kchnet.or.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel
0864220210
kenkyu@kchnet.or.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
| 2019 | Year | 03 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041109
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
