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

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 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

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

Value
https://center6.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