UMIN-CTR Clinical Trial

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
Email	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
Email	mu13951@kchnet.or.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055821