UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034661 |
|---|---|
| Receipt number | R000039515 |
| Scientific Title | Retrospective study comparing radiofrequency ablation and proton beam therapy for treatment naive solitary hepatocellular carcinoma: a propensity score analysis |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/11/05 06:58:27 |
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Basic information
Public title
Retrospective study comparing radiofrequency ablation and proton beam therapy for treatment naive solitary hepatocellular carcinoma: a propensity score analysis
Acronym
HCC RFA-Proton
Scientific Title
Retrospective study comparing radiofrequency ablation and proton beam therapy for treatment naive solitary hepatocellular carcinoma: a propensity score analysis
Scientific Title:Acronym
HCC RFA-Proton
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively investigate efficacy and safety of Proton beam therapy comparing with radiofrequency ablation for treatment naive solitary hepatocellular carcinoma: A propensity score analysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (Five-year overall survival rate)
Key secondary outcomes
Local control period (Five-year Local control rate), progression free survival (Five-year progression free survival rate), Adverse event
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
1) Histologically or clinically diagnosed primary hepatocellular carcinoma. Untreated and absence of previous local therapy.
2) Absence of vascular invasion.
3) ECOG PS: 0-2.
4) Child-Pugh score of the patient is from 5 points to 8 points.
5) The tumor is measurable and tumor size is less than 5 cm.
6) Solitary tumor
Key exclusion criteria
1) Having extrahepatic lesions.
2) Previously treated with percutaneous ethanol injection therapy
3) Total bilirubin is more than 3.0 mg/dL
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Sakurai |
Organization
University of Tsukuba
Division name
Dept. of Radiation Oncology, Faculty of Medicine
Zip code
305-0005
Address
2-1-1, Amakubo, Tsukuba, Ibaraki
TEL
029-853-7100
hsakurai@pmrc.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Okumura |
Organization
University of Tsukuba
Division name
Dept. of Radiation Oncology, Faculty of Medicine
Zip code
305-0005
Address
2-1-1, Amakubo, Tsukuba, Ibaraki
TEL
029-853-7100
Homepage URL
okumura@pmrc.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Proton Medical Research Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastroenterology,
The University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University Hospital IRB
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
2-1-1 Amakubo, Tsukuba, Ibaraki
rinshokenkyu@un.tsukuba.ac.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
筑波大学附属病院（茨城県） University of Tsukuba Hospital、東京大学医学部附属病院（東京都） The University of Tokyo Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Overall survival (Five-year overall survival rate)
Recurrence free survival
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039515
