UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060556 |
|---|---|
| Receipt number | R000066841 |
| Scientific Title | A Multicenter, Prospective REgistry study of Stereotactic body radioTherapy for hepatOcellular carcinoma |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/02 20:14:50 |
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Basic information
Public title
A Prospective REgistry study of Stereotactic body radioTherapy for hepatOcellular carcinoma
Acronym
PRESTO study
Scientific Title
A Multicenter, Prospective REgistry study of Stereotactic body radioTherapy for hepatOcellular carcinoma
Scientific Title:Acronym
PRESTO study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will prospectively register cases of stereotactic body radiotherapy (SBRT) for small hepatocellular carcinoma (HCC) treated at multiple institutions nationwide, evaluate the therapeutic efficacy and safety of SBRT, and clarify the actual treatment conditions in real-world settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year overall survival
Key secondary outcomes
Overall survival, 3-year overall survival rate, progression-free survival, 5 years (3 years) progression-free survival rate, , local disease-free survival, 5 years (3 years) local disease-free survival rate, 5 years (3 years) local control rate, intrahepatic disease-free survival, 5 years (3 years) intrahepatic disease recurrence rate, extrahepatic (lymph node + distant) metastasis-free survival period, 5-year (3-year) extrahepatic (lymph node + distant) metastasis recurrence rate, disease-specific survival period, 5-year (3-year) disease-specific survival rate, 5-year (3-year) liver failure mortality rate, 5-year (3 years) Liver-related survival rate (including both primary disease death and liver failure death as events), incidence of adverse events, incidence of Grade 2 or 3 or higher adverse events, proportion of patients with worsening liver function (Child-Pugh 2 or higher), treatment for first recurrence
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases treated with SBRT at JROSG-participating facilities or JASTRO-certified facilities that meet the following criteria are eligible.
1) Liver function: Child-Pugh class A or B.
2) Primary or recurrent HCC. Prior treatment for recurrent HCC may include surgery, TACE, percutaneous therapy, or SBRT at a different site.
3) Tumor size of 3 cm or less in total with no more than 3 lesions, or a single lesion of 5 cm or less. In cases of multiple lesions where SBRT is performed on only part of the lesions, the remaining lesions must undergo curative RFA or surgery. Other radiation therapy for other lesions (excluding those described in item 5 below) is not permitted.
4) Pathologically diagnosed as HCC, or demonstrating typical HCC contrast-enhancing findings on abdominal contrast-enhanced CT (dynamic CT for the liver), abdominal contrast-enhanced MRI (dynamic MRI), or Sonazoid US, characterized by high contrast enhancement in the early phase and low contrast enhancement in the late phase.
5) Cases where SBRT (with a central dose or maximum dose of BED10 >=100 Gy, delivered in 8 fractions or fewer) is feasible.
6) Written informed consent for trial participation has been obtained from the patient.
Key exclusion criteria
1) Tumor embolization in major branches of the portal vein, hepatic vein, or bile duct (Vp3, 4, Vv2, 3, B3, 4) (3.3.2.1. Vascular invasion/bile duct invasion).
2) Lymph node metastasis or distant metastasis is present.
3) Previous radiation therapy to the same site with concerns about safety for adjacent critical organs.
4) Previous registration in this study.
5) Esophageal varices requiring treatment.
6) Active infection (excluding HBV/HCV).
7) Active concurrent cancer (including synchronous and metachronous cancers with a disease-free interval of 3 years or less). However, the following are excluded from active concurrent cancer: carcinoma in situ deemed curable by local therapy; lesions equivalent to intraepithelial or mucosal cancer; WHO classification T1N0M0 laryngeal cancer (glottic origin); localized prostate cancer; stage I breast cancer; and cancers with an expected prognosis equivalent to these.
8) Concurrent mental illness or psychiatric symptoms that make participation in this trial or follow-up observation difficult.
9) Pregnancy or possibility of pregnancy.
10) History of systemic drug therapy for HCC.
11) Other conditions deemed inappropriate for participation in this trial by the responsible physician.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Kimura |
Organization
Kochi University
Division name
Department of Radiation Oncology/ Kochi Medical School Hospital
Zip code
783-8505
Address
185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan
TEL
088-880-0419
tkkimura@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Sanuki |
Organization
Keio University Hospital
Division name
Department of Radiation Oncology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
https://jrosg.jp
naokosanuki@icloud.com
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japanese Radiation Oncology Study Group (JROSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kochi University Medical School
Address
185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
Tel
088-880-0419
tkkimura@kochi-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JROSG24-2
Org. issuing International ID_1
Japanese Radiation Oncology Study Group (JROSG)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌医科大学附属病院（北海道）、北海道大学病院（北海道）、岩手医科大学附属病院（岩手県）、東北大学病院（宮城県）、山形大学医学部附属病院（山形県）、ひたちなか総合病院（茨城県）、埼玉医科大学総合医療センター（埼玉県）、さいたま市立病院（埼玉県）、量子科学技術研究開発機構QST病院（千葉県）、順天堂大学医学部附属浦安病院（千葉県）、がん・感染症センター東京都立駒込病院（東京都）、国立がん研究センター中央病院（東京都）、慶應義塾大学病院（東京都）、昭和医科大学病院（東京都）、帝京大学医学部附属病院（東京都）、東京医科大学病院（東京都）、東京慈恵会医科大学附属病院（東京都）、東京都済生会中央病院（東京都）、東京大学医学部附属病院（東京都）、東邦大学医療センター大森病院（東京都）、日本大学医学部附属板橋病院（東京都）、大船中央病院（神奈川県）、湘南藤沢徳洲会病院（神奈川県）、東海大学医学部付属病院（神奈川県）、新潟県立がんセンター新潟病院（新潟県）、富山大学附属病院（富山県）、山梨大学医学部附属病院（山梨県）、長野赤十字病院（長野県）、聖隷三方原病院（静岡県）、静岡がんセンター（静岡県）、浜松医科大学医学部附属病院（静岡県）、名古屋大学医学部附属病院（愛知県）、伊勢赤十字病院（三重県）、京都大学医学部附属病院（京都府）、京都桂病院（京都府）、大阪医科薬科大学病院（大阪府）、大阪国際がんセンター（大阪府）、大阪急性期・総合医療センター（大阪府）、大阪大学医学部附属病院（大阪府）、関西医科大学附属病院（大阪府）、近畿大学病院（大阪府）、彩都友紘会病院（大阪府）、都島放射線科クリニック（大阪府）、神戸市立医療センター中央市民病院（兵庫県）、神戸大学医学部附属病院（兵庫県）、神戸低侵襲がん医療センター（兵庫県）、兵庫医科大学病院（兵庫県）、兵庫県立がんセンター（兵庫県）、兵庫県立はりま姫路総合医療センター（兵庫県）、明和キャンサークリニック（兵庫県）、近畿大学奈良病院（奈良県）、日本赤十字社和歌山医療センター（和歌山県）、和歌山県立医科大学附属病院（和歌山県）、倉敷中央病院（岡山県）、県立広島病院（広島県）、広島がん高精度放射線治療センター（広島県）、広島大学病院（広島県）、山口大学医学部附属病院（山口県）、高知大学医学部附属病院（高知県）、佐世保市総合医療センター（長崎県）、長崎医療センター（長崎県）、長崎大学病院（長崎県）、日本赤十字社長崎原爆病院（長崎県）、熊本大学病院（熊本県）、琉球大学病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will register patients treated with standard-of-care radiotherapy in routine clinical practice, in order to characterize real-world treatment outcomes and adverse events.
Management information
Registered date
| 2026 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066841
