UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of stereotactic body radiotherapy for liver tumor using hypoxia imaging
Acronym	Prediction of liver stereotactic body radiotherapy
Scientific Title	Prediction of stereotactic body radiotherapy for liver tumor using hypoxia imaging
Scientific Title:Acronym	Prediction of liver stereotactic body radiotherapy
Region	Japan

Condition
Condition	liver tumors
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish a standard protocol of liver stereotactic radiotherapy and to evaluate the affects of the hypoxic area on the efficacy of stereotactic body radiotherapy for liver tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	two-year local control
Key secondary outcomes	overall survival, progression-free survival, local progression-free survival (local control), failure pattern, rate of completion of the treatment, incidence of toxicity, incidence of severe toxicity, volume of focal liver radiation damage and association of radiation-doses, validation among images, treatment planning, and images of image-guided radiotherapy, validation of set-up, intra-fraction, and inter-fraction errors, optimization of radiotherapy to minimize radiation exposure in radiotherapy, evaluation of accuracy of radiotherapy, differences between primary and metastatic liver tumors

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	stereotactic body radiotherapy
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 liver tumors (5 cm or less) can receive stereotactic radiotherapy 2 medically inoperable or refusal of surgery 3 Performance status (ECOG) 0-2 4 20 years old or elder 5 written informed consent in the first-person (writing for the first-person on behalf of him/her is permitted)
Key exclusion criteria	1. pregnancy or possible pregnancy 2. existence of severe systematic disease 3. Child-Pugh C 4. medical history of radiotherapy for upper abdomen 5. other (physician's decision)
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasumasa Middle name Last name Nishimura
Organization	Kindai University Faculty of Medicine
Division name	Department of Radiation Oncology
Zip code	589-0014
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka, Japan.
TEL	072-366-0221
Email	ynishi@med.kindai.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Doi
Organization	Kindai University Faculty of Medicine
Division name	Department of Radiation Oncology
Zip code	589-0014
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka, Japan.
TEL	072-366-0221
Homepage URL
Email	h-doi@med.kindai.ac.jp

Sponsor
Institute	Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization	Kindai University Faculty of Medicine
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	Kindai University Faculty of Medicine
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.
Tel	072-366-0221
Email	zizen@med.kindai.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	近畿大学医学部（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 06 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	Terminated
Date of protocol fixation	2017 Year 08 Month 24 Day
Date of IRB	2017 Year 11 Month 28 Day
Anticipated trial start date	2017 Year 11 Month 28 Day
Last follow-up date	2023 Year 11 Month 27 Day
Date of closure to data entry	2023 Year 11 Month 27 Day
Date trial data considered complete	2023 Year 11 Month 27 Day
Date analysis concluded	2025 Year 11 Month 27 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 06 Day
Last modified on	2022 Year 12 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033286