UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Acronym	Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Scientific Title	Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Scientific Title:Acronym	Evaluation of the clinical outcome and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the clinical outcomes and cost effectiveness of carbon ion radiotherapy or transarterial chemoembolization to localized hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival rate Local control rate Cost effectiveness
Key secondary outcomes

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with localized HCC treated with C-ion RT or TACE.
Key exclusion criteria	The patient with: 1) direct infiltration of the gastrointestinal tract; 2) intrahepatic metastasis; 3) distant metastasis, and; 4) major vascular invasion were excluded.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Kei Middle name Last name Shibuya
Organization	Gunma University Graduate School of Medicine
Division name	Department of Radiation Oncology
Zip code	371-8511
Address	3-39-22, Syowa-machi, Maebashi, Gunma
TEL	027-220-8383
Email	shibukei@gunma-u.ac.jp

Public contact
1st name of contact person	1st name Shintaro Middle name Last name Shiba
Organization	Gunma University Graduate School of Medicine
Division name	Department of Radiation Oncology
Zip code	371-8511
Address	3-39-22, Syowa-machi, Maebashi, Gunma
TEL	027-220-8383
Homepage URL
Email	shiba4885@yahoo.co.jp

Sponsor
Institute	Department of Radiation Oncology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Radiation Oncology, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gunma University Hospital Institutional Review Board
Address	3-39-15, Syowa-machi, Maebashi, Gunma
Tel	027-220-8740
Email	gunma-ciru@ml.gunma-u.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

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 10 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	54
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	2019 Year 03 Month 22 Day
Date of IRB	2019 Year 03 Month 22 Day
Anticipated trial start date	2019 Year 03 Month 22 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	Retrospective analysis

Management information
Registered date	2019 Year 04 Month 09 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041544