UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Acronym	Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Scientific Title	Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Scientific Title:Acronym	Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Region	Japan

Condition
Condition	solitary primary 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 image-guided proton therapy for solitary primary hepatocellular carcinoma that was amenable to standard treatment (resection or ablation)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year overall survival
Key secondary outcomes	local control rate, progression free survival,response rate,incidence of grade 3 or higher adverse events,change of quality of life (QOL)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	image-guided proton therapy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) histologically-confirmed or image-diagnosed solitary primary HCC staged as T1N0M0 (UICC TNM 7th ed.) 2) no history of previous HCC 3) patient refusal of surgery or radiofrequency ablation 4) no previous radiotherapy around the lesion 5) age: 20-80 years old 6) ECOG-PS: 0-1 7) Child-Pugh classification A5, 6 or B7 8) dose constraints of the organs at risk achievable 9) tumor diameter < 12 cm 10) written informed consent
Key exclusion criteria	1)pregnancy or lactation 2)severe psychological disorders 3)active and uncontrolled infection 4)Other cancers within 5 years 5)continuous systemic administration (oral or intravenous) of steroids 6)esophageal varix at high risk of bleeding (F3, Rc ++ or higher) 7)portal vein tumor thrombosis 8)cases in which the doctor is judged inappropriate for medical, psychological or other reasons other than the above
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Ogino
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Email	oginogio@gmail.com

Public contact
Name of contact person	1st name Hiromitsu Middle name Last name Iwata
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Homepage URL
Email	h-iwa-ncu@nifty.com

Sponsor
Institute	Nagoya City West Medical Center
Institute
Department

Funding Source
Organization	Nagoya City West Medical Center,Nagoya Proton Therapy Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Study Committees of the Nagoya City Hospital
Address	1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel	052-721-7171
Email	rinsho1@higashi-hosp.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 05 Month 20 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	45
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	Completed
Date of protocol fixation	2013 Year 03 Month 28 Day
Date of IRB	2013 Year 03 Month 19 Day
Anticipated trial start date	2013 Year 06 Month 15 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 14 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041868