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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034661
Receipt No. 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 2019/04/27

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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
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Overall survival (Five-year overall survival rate)

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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