UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062868 |
|---|---|
| Receipt number | R000071967 |
| Scientific Title | Clinical trial of 4-fraction proton beam therapy for peripheral hepatocellular carcinoma 4 cm or lager in diameter |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/10 10:50:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical trial of 4-fraction proton beam therapy for peripheral hepatocellular carcinoma 4 cm or lager in diameter
Acronym
Four-fraction proton beam therapy for peripheral hepatocellular carcinoma
Scientific Title
Clinical trial of 4-fraction proton beam therapy for peripheral hepatocellular carcinoma 4 cm or lager in diameter
Scientific Title:Acronym
Four-fraction proton beam therapy for peripheral hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Peripheral hepatocellular carcinoma 4 cm or lager in diameter
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of a four-fraction proton beam therapy regimen for hepatocellular carcinoma measuring 4 cm or larger that meets the eligibility criteria.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-year local control rate
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Four-fraction proton beam therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with a diagnosis of hepatocellular carcinoma confirmed histologically or via MRI
(2) Patients with a localized liver tumor of 4 cm or larger eligible for insurance coverage
(3) Patients with Child-Pugh class A or B liver function
(4) Performance status (PS) (ECOG) 0-2
(5) Patients aged 20 years or older
(6) Patients capable of maintaining the required body position during irradiation and for whom proton beam therapy is technically feasible
(7) Patients who have received an explanation using the designated document and have provided written consent
Key exclusion criteria
Cases meeting any of the following criteria will be excluded:
(1) Tumor located within 2 cm of the gastrointestinal tract or hepatic hilum
(2) History of prior radiotherapy to the planned treatment area
(3) Uncontrolled ascites
(4) Active, refractory infection
(5) Serious complications
(6) Active multiple primary cancers Note: Prostate cancer is excluded if deemed cured by local treatment.
(7) Otherwise judged by the study physician(s) as unsuitable for the safe conduct of this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Murakami |
Organization
Southern TOHOKU Proton Therapy Center
Division name
Radiation Oncology
Zip code
963-8052
Address
7-172 Yatsuyamada, Koriyama City, Fukushima Prefecture
TEL
023-934-3888
abc1123513@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ono |
Organization
Southern TOHOKU Proton Therapy Center
Division name
Radiation Oncology
Zip code
963-8052
Address
7-172 Yatsuyamada, Koriyama City, Fukushima Prefecture
TEL
023-934-3888
Homepage URL
abc1123513@gmail.com
Sponsor or person
Institute
Southern TOHOKU Proton Therapy Center
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
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU General Hospital
Address
7-115 Yatsuyamada, Koriyama City, Fukushima Prefecture
Tel
024-934-5412
kenkyukanri@mt.strins.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
| 2026 | Year | 09 | Month | 14 | 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
| 2026 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071967
