UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Title of the study (Brief title)	Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	3-year local control rate
Key secondary outcomes	Overall survival Progression free survival Response rate Acute toxicity(within 6 months) Late toxicity(6 months or later)

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) pathollogically or clinically diagnosed hepatocellular carcinoma. 2) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor. 3) Tumor is measurable and tumor size is 10 cm or less than 10 cm. 4) Absence of invasion to the main branch of portal vein, common hepatic duct, or inferior vena cava. 5) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition) 6) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE. 7) No other intrahepatic lesion or at least 2 years passed after the previous curative therapy to other intraheaptic lesions. 8) Perfomance status of the patient is from 0 to 2. 9) Child-Pugh score of the patient is from 5 points to 9 points. 10) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria	1) History of radiation therapy to the lesion of interest. 2) The alimentary tract was adjacent to the target lesion. 3) Patients with any other active malignancies. 4) Patient with severe comorbidity.
Target sample size	35

Research contact person
Name of lead principal investigator	Takashi Nakano
Organization	Gunma University
Division name	Heavy Ion Medical Center
Address	3-39-22 Showa, Maebashi, Gunma
TEL	027-220-8378
Email	tnakano@gunma-u.ac.jp

Public contact
Name of contact person	Tatsuya Ohno
Organization	Gunma University
Division name	Heavy Ion Medical Center
Address	3-39-22 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)

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	2016 Year 01 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design:Prospective cohort study Recruitment of patients: All patients who meet all inclusion criteria and not meet any exclusion criteria with hepatocellular carcinoma treated by heavy-ion particle therapy in Gunma university Heavy ion medical center. Patients who had been included into other clinical trials were excluded.

Management information
Registered date	2016 Year 01 Month 14 Day
Last modified on	2018 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023750