UMIN-CTR Clinical Trial

Basic information
Public title	Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Acronym	Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Scientific Title	Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Scientific Title:Acronym	Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
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 proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies in a multicenter study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	3-year overall survival rate
Key secondary outcomes	1) 3-year progression free survival rate 2) 3-year local control rate 3) incidence of adverse events 4) 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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Proton beam therapy A total dose of 66GyE (RBE=1.1) in 10 fractions (5 fractions/week) For tumors within 2cm of the ports hepatic or gastrointestinal tract, a total dose of 72.6 GyE (RBE=1.1) in 22 fractions (5 fractions/week)
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) Pathologically proven or Radiologically diagnosed hepatocellular carcinoma (HCC) on dynamic CT or dynamic MRI within 28 days before registration 2) No prior treatment for HCC 3) Solitary HCC without extrahepatic lesions on chest and abdominal CT within 28 days before registration 4) Measurable tumor on dynamic CT or dynamic MRI within 28 days before registration and maximum tumor diameter <= 12 cm in the axial plane 5) Absence of invasion of the main trunk and/or major branches of the portal vein and the bile duct, or the inferior vena cava 6) No contact with the gastrointestinal tract 7) Unsuitable for resection or liver transplantation judged by a multidisciplinary meeting, prediction of severe deterioration in liver function after hepatic resection based on ICG R15, 99mTc-GSA scintigraphy, or CT volumetry 8) Unsuitable or difficult to undergo local ablative therapies judged by a multidisciplinary meeting 9) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2 within 14 days before registration 10) Liver function of Child-Pugh class A within 14 days before registration 11) Absence of uncontrolled pleural effusion or ascites within 28 days before registration 12) Vital organ functions (listed below) are preserved within 14 days before registration WBC count >= 1,500/mm3; hemoglobin level >= 7.0 g/dL; platelet count >= 30,000/mm3; total bilirubin <= 3.0 mg/dL; sGOT (AST) and sGPT (ALT) < 5.0 x upper limit of normal 13) Age 20-years old or over at the time of obtaining the consent form 14) Given written informed consent to this study
Key exclusion criteria	1) With other malignancies (simultaneous double cancer and heterochronic double cancer with disease-free time within 5 years), excluding lesions equivalent to carcinoma-in-situ or submucosal carcinoma 2) With esophageal or gastric varices at high risk for rupture within 28 days before registration 3) With active infection requiring systemic therapy 4) With a fever of 38 degrees Celsius or more 5) With cardiac infarction or unstable angina within 6 months before registration 6) With interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema 7) Allergic to radiation 8) Considered that participation in this trial is difficult due to psychiatric symptoms or psychosis 9) Females who are pregnant, breast-feeding, within 28 days postpartum or have a possibility of conception 10) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Shirato
Organization	Hokkaido University Hospital
Division name	Department of Radiation Oncology
Zip code	060-8648
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido
TEL	011-706-5977
Email	shirato@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Norio Middle name Last name Katoh
Organization	Hokkaido University Hospital
Division name	Department of Radiation Oncology
Zip code	060-8648
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido
TEL	011-706-5977
Homepage URL
Email	noriwokatoh@med.hokudai.ac.jp

Sponsor
Institute	Department of Radiation Oncology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	AMED(Japan)
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	Hokkaido University Clinical Research Review Board
Address	North 14 West 5, Kita-Ku, Sapporo, Hokkaido
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	2016 Year 01 Month 18 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	30
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	Terminated
Date of protocol fixation	2016 Year 05 Month 12 Day
Date of IRB	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 06 Month 15 Day
Last follow-up date	2020 Year 04 Month 22 Day
Date of closure to data entry	2020 Year 05 Month 21 Day
Date trial data considered complete	2020 Year 06 Month 08 Day
Date analysis concluded	2020 Year 06 Month 26 Day

Other
Other related information

Management information
Registered date	2016 Year 01 Month 16 Day
Last modified on	2020 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023097