UMIN-CTR Clinical Trial

Basic information
Public title	A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma
Acronym	HCC-SBRT P1 Study
Scientific Title	A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma
Scientific Title:Acronym	HCC-SBRT P1 Study
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the safety of stereotactic body radiotherapy for limited hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence of dose limitting toxicity(DLT)
Key secondary outcomes	Tumor response Local progression free survival Progression free survival Overall survival Adverse effects

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	Device,equipment
Interventions/Control_1	A total dose of 32-64 Gy is delivered in 4 fractions over 4-8 days
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 or radiologically diagnosed hepatocellular carcinoma 2) Single lesion with 5 cm or less in size 3) Ineligible for surgical resection 4) Ineligible for percutaneous local ablative therapy 5) Liver function with Child pugh score 5-6 (class A) or 7-8 (class B) 6) Normal liver volume of 800ml or more 7) Satisfy the liver tolelance dose 8) Dose not exceed the tolelance dose of surrounding normal tissues 9) ECOG Performance Status of 0-2
Key exclusion criteria	1) Uncontrolled ascites 2) Gastric/esophageal varix which needs preventive treatment 3) Tumor thrumbus in main trunk of portal vein or IVC 4) Case with critical complication 5) Simultaneous cancer 6) In pregnancy or with expectation of pregnancy
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Itami
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Division of Radiation Oncology
Zip code
Address	5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL	03-3542-2511
Email	mayah1jp@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Mayahara
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Division of Radiation Oncology
Zip code
Address	Tsukiji 5-1-1, Chuo-Ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	mayah1jp@yahoo.co.jp

Sponsor
Institute	Division of Radiation Oncology and division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization
Address
Tel
Email

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	国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information	2010 Year 01 Month 25 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	Completed
Date of protocol fixation	2010 Year 01 Month 01 Day
Date of IRB	2010 Year 01 Month 05 Day
Anticipated trial start date	2010 Year 01 Month 05 Day
Last follow-up date	2019 Year 03 Month 14 Day
Date of closure to data entry	2019 Year 03 Month 14 Day
Date trial data considered complete	2019 Year 03 Month 14 Day
Date analysis concluded	2019 Year 03 Month 14 Day

Other
Other related information

Management information
Registered date	2010 Year 01 Month 25 Day
Last modified on	2020 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003751