UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062024 |
|---|---|
| Receipt number | R000070973 |
| Scientific Title | An in silico study comparing dose distributions between carbon ion radiotherapy and stereotactic body radiotherapy for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/23 12:53:18 |
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Basic information
Public title
An in silico study comparing dose distributions between carbon ion radiotherapy and stereotactic body radiotherapy for hepatocellular carcinoma.
Acronym
An in silico study comparing dose distributions between carbon ion radiotherapy and stereotactic body radiotherapy for hepatocellular carcinoma.
Scientific Title
An in silico study comparing dose distributions between carbon ion radiotherapy and stereotactic body radiotherapy for hepatocellular carcinoma.
Scientific Title:Acronym
An in silico study comparing dose distributions between carbon ion radiotherapy and stereotactic body radiotherapy for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify clinical conditions in which carbon ion radiotherapy is advantageous by generating dose distributions for stereotactic body radiotherapy (SBRT) in patients with hepatocellular carcinoma (tumor diameter under 5 cm) treated with carbon ion radiotherapy at our institution, and comparing them with the dose distributions of carbon ion radiotherapy, taking into account tumor size and location.
Basic objectives2
Others
Basic objectives -Others
By comparing dose distributions of carbon ion radiotherapy and stereotactic body radiotherapy (SBRT) using treatment planning CT, this study aims to clarify the respective advantages of each modality.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose to the normal liver in stereotactic body radiotherapy (SBRT) and carbon ion radiotherapy for hepatocellular carcinoma measuring under 5 cm.
Key secondary outcomes
Dose to other normal tissues and residual liver volume in carbon ion radiotherapy and stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma measuring under 5 cm.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hepatocellular carcinoma who underwent carbon-ion radiotherapy between January 2025 and December 2025
Patients with a maximum tumor diameter of <5 cm before treatment
Key exclusion criteria
Patients who opted out of the use of their information for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3360
wakatsuki.masaru@qst.go.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospoital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3360
Homepage URL
wakatsuki.masaru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology (QST)
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
National Institutes for Quantum Science and Technology (QST)
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-3360
wakatsuki.masaru@qst.go.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
国立研究開発法人量子科学技術研究開発機構(QST) QST病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An in silico study using treatment planning CT
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070973
