UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049003 |
|---|---|
| Receipt number | R000055821 |
| Scientific Title | Prospective feasibility study of ultrasonography-combined follow-up approach for post-radiotherapy hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2022/11/06 03:29:52 |
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Basic information
Public title
Prospective feasibility study of ultrasonography-combined follow-up approach for post-radiotherapy hepatocellular carcinoma
Acronym
US-POSTR study
Scientific Title
Prospective feasibility study of ultrasonography-combined follow-up approach for post-radiotherapy hepatocellular carcinoma
Scientific Title:Acronym
US-POSTR study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the feasibility of a novel follow-up approach with ultrasonography and contrast-enhanced CT/MRI for hepatocellular carcinoma after stereotactic body radiotherapy (SBRT)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of addition of contrast-enhanced CT/MRI at 3 or 9 momths after radiotherapy
Key secondary outcomes
1) Reasons for addition of contrast-enhanced CT/MRI
2) Tumor detection rates at 3 and 9 months by ultrasonography
3) Tumor detection rates at 6 and 12 months by contrast-enhanced CT/MRI
4) Local control rates at 3, 6, 9 and 12 months
5) Time to local progression
6) Overall survival
7) Adverse events due to contrast agents
8) Total number of contrast-enhanced CT/MRI during follow-up period
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
1) Abdominal ultrasonography at 3 and 9 months after radiotherapy
2) Contrast-enhanced CT/MRI at 6 and 12 months after radiotherapy
3) Evaluation of tumor markers at 3, 6, 9 and 12 months after radiotherapy
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
1) Age 18 years or higher
2) Histologically or radiologically diagnosed hepatocellular carcinoma
3) Tumor number 3 or less; tumor size 5 cm or less
4) Undergoing SBRT for a single tumor
5) Well visualized by non-contrast ultrasonography
6) Informed consent obtained
Key exclusion criteria
1) Three months or longer duration between pretreatment radiological evaluation and SBRT
2) Apparent vascular invasion and/or metastasis
3) Unable to perform contrast-enhanced CT/MRI
4) Other diseases requiring more frequent contrast-enhanced CT/MRI
5) Considered not appropriate as a participant of this study by investigators
Target sample size
36
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
Miwa 1-1-1, Kurashiki, Okayama, 710-8602, Japan
TEL
086-422-0210
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
Miwa 1-1-1, Kurashiki, Okayama, 710-8602, Japan
TEL
086-422-0210
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Kurashiki Central Hospital
Address
Miwa 1-1-1, Kurashiki, Okayama, 710-8602, Japan
Tel
086-422-0210
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
| 2022 | Year | 09 | Month | 22 | 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
| 2022 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055821
