UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)
Title of the study (Brief title)	Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)
Region	Japan

Condition
Condition	Primary liver cancer
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 safety of carbon-ion radiotherapy using 12 fractions for liver cancer adjacent to the alimentary tract.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dose-limiting toxicity Acute toxicity
Key secondary outcomes	Response rate Late toxicity

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 Total dose 60.0-64.8 Gy(RBE) 12 fractions
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 primary liver tumor (hepatocellular carcinoma or cholangiocellular carcinoma). 2) The distance between taget lesion and digestive tract is 1 cm or less than 1 cm. 3) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor. 4) Tumor is measurable and tumor size is 10 cm or less than 10 cm. 5) Absence of invasion to the main portal vein, common hepatic duct, or inferior vena cava. 6) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition) 7) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE. 8) Child-Pugh score of the patient is from 5 points to 9 points. 9) Perfomance status of the patient is from 0 to 2. 8) Child-Pugh score of the patient is from 5 points to 9 points. 9) Expected survival over 6 months. 10) Perfomance status of the patient is from 0 to 2. 11) 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) Invasion to the adjacent organs. 3) Patient with severe comorbidity.
Target sample size	6

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 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 06 Day
Anticipated trial start date	2013 Year 07 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

Management information
Registered date	2016 Year 01 Month 05 Day
Last modified on	2017 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023505