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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030279
Receipt No. R000033286
Scientific Title Prediction of stereotactic body radiotherapy for liver tumor using hypoxia imaging
Date of disclosure of the study information 2017/12/06
Last modified on 2019/06/11

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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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 24 Day
Date of IRB
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
2019 Year 06 Month 11 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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