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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025342
Receipt No. R000029161
Official scientific title of the study Efficacy and safety of proton beam therapy in patients with previously untreated hepatocellular carcinoma
Date of disclosure of the study information 2016/12/20
Last modified on 2016/12/20

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Basic information
Official scientific title of the study Efficacy and safety of proton beam therapy in patients with previously untreated hepatocellular carcinoma
Title of the study (Brief title) Proton beam therapy for hepatocellular carcinoma
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of proton beam therapy in patients with previously untreated hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes overall survival
Key secondary outcomes local tumor control rate, progression free survival, adverse events

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
Device,equipment
Interventions/Control_1 Proton beam therapy
66 -77 GyE /10 - 35 fractions (days)
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 Previously untreated hepatocellular carcinoma
ECOG-PS: 0-2
Child-Pugh grade: A or B
Non-irradiated normal liver volume: >= 500ml
The tumor could be covered within the same irradiation field <= 135mm
Key exclusion criteria massive ascites
Target sample size 129

Research contact person
Name of lead principal investigator Hideyuki Sakurai
Organization University of Tsukuba
Division name Radiation oncology
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL +81-29-853-7100
Email hsakurai@pmrc.tsukuba.ac.jp

Public contact
Name of contact person Kuniaki Fukuda
Organization University of Tsukuba
Division name Gastroenterology
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL +81-29-853-3218
Homepage URL
Email k-fukuda@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 20 Day

Progress
Recruitment status Completed
Date of protocol fixation
2001 Year 12 Month 01 Day
Anticipated trial start date
2002 Year 01 Month 13 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 06 Month 30 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 12 Month 20 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029161

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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