UMIN-CTR Clinical Trial

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
Email	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
Email	okumura@pmrc.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba, Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039515