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Name:
UMIN ID:

Recruitment status Recruiting
Unique ID issued by UMIN UMIN000002172
Receipt No. R000002667
Official scientific title of the study Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC, PhaseI/II study
Date of disclosure of the study information 2009/07/14
Last modified on 2012/08/28

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Basic information
Official scientific title of the study Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC, PhaseI/II study
Title of the study (Brief title) Ion beam therapy with concurrent hepatic arterial infusion chemotherapy for advanced HCC
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and therapeutic effect of ion beam theraphy with concurrent arterial infusion chemotherapy for advanced HCC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes side effect, survival time and QOL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Hepatic arterial infusion chemotherapy
Ion beam therapy(proton therapy, carbon-ion therapy)
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
80 years-old >
Gender Male and Female
Key inclusion criteria Unresectable HCC with tumor thronbosis and multiple intrahepatic metastases
Key exclusion criteria Distal metastases
Acsites
Target sample size 30

Research contact person
Name of lead principal investigator Masao Murakami
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address 1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL 0791-58-0100
Email

Public contact
Name of contact person Kazuki Terashima
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address 1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL 0791-58-0100
Homepage URL
Email terashima@kmyr.jp

Sponsor
Institute Department of Radiology, Hyogo Ion Beam Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 14 Day

Progress
Recruitment status Recruiting
Date of protocol fixation
2009 Year 04 Month 01 Day
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

Management information
Registered date
2009 Year 07 Month 08 Day
Last modified on
2012 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002667

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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