UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Acronym	Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Scientific Title	Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Scientific Title:Acronym	Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the carbon-ion radiation therapy for hepatocellular carcinoma in multi-institutional setting.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival (Three-year overall survival)
Key secondary outcomes	Progression free survival (Three-year), Local progression free survival (Three-year), Adverse event, Incidence of radiation-induced liver disease(RILD)

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	Maneuver
Interventions/Control_1	Carbon-ion radiation therapy 60 Gy(RBE) / 4 fractions 60 Gy(RBE) / 12 fractions (adjacent to organ at risk)
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. 2) Untreated and absence of previous local therapy. 3) Solitary tumor without extrahepatic lesions. 4) The tumor is measurable and tumor size is less than 12 cm. 5) Absence of major portal vein and/or hepatic vein. 6) The tumor is in contact with the alimentary tract. 7) Unfit for resection or liver transplantation. 8) Unfit for percutaneous tumor ablation. 9) ECOG PS: 0-2. 10) Child-Pugh score of the patient is from 5 points to 9 points. 11) Absence of uncontrolled ascites and/or pleural effusion. 12) 20-year-old or older. 13) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria	1) Patients with any other active malignancies. 2) Having esophageal varices which are at great risk of bleeding 3) Having active infectious diseases 4) Having a fever greater than 38 degrees Celsius. 5) Having myocardial infarction or angina pectoris within 6 months. 6) Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema. 7) Having radiation hypersensitivity. 8) Associated with mental illness or manifestation complicating study participation. 9) Being pregnant or possible conception. 10) Miscellaneous inappropriate conditions judged by physicians.
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Ohno
Organization	Gunma University Hospital
Division name	Department of radiation oncology
Zip code	371-8511
Address	3-39-22 Showa, Maebashi, Gunma
TEL	027-220-8378
Email	tnakano@gunma-u.ac.jp

Public contact
Name of contact person	1st name Kei Middle name Last name Shibuya
Organization	Gunma University
Division name	Heavy Ion Medical Center
Zip code	371-8511
Address	3-39-15 Showa, Maebashi, Gunma
TEL	027-220-8378
Homepage URL
Email	tohno@gunma-u.ac.jp

Sponsor
Institute	Gunma University Heavy Ion Medical Center
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa, Maebashi, Gunma
Tel	027-220-7111
Email	nakamurt@gunma-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCT1032200036
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 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
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	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 28 Day
Date of IRB	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2027 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 05 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023620