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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040093
Receipt No. R000045715
Scientific Title A multi-institutional prospective observational study of LINAC-based single isocenter stereotactic irradiation for multiple brain metastases
Date of disclosure of the study information 2020/04/07
Last modified on 2020/04/07

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Basic information
Public title A multi-institutional prospective observational study of LINAC-based single isocenter stereotactic irradiation for multiple brain metastases
Acronym SISTI study
Scientific Title A multi-institutional prospective observational study of LINAC-based single isocenter stereotactic irradiation for multiple brain metastases
Scientific Title:Acronym SISTI study
Region
Japan

Condition
Condition brain metastases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and feasibility of LINAC-based single isocenter stereotactic irradiation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Local control rate at 6 months after LINAC-based single isocenter stereotactic irradiation per case
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)20 years old or higher
2)Diagnosed as solid malignant tumors (except small-cell lung cancer and malignant lymphoma)
3)2 or more brain metastases as counted on a gadolinium contrast-enhanced MRI (maximum 10 brain metastases)
4)The longest diameter of each gross tumor volume (GTV) is smaller than 3 cm, and each GTV is smaller than 10 cm3. Total volume of all GTV is smaller than 15 cm3.
5)Performance status 0-2 or 3 (only if caused by the tumor)
6)No leptomeningeal metastases
7)No previous surgery or irradiation to the skull or brain.
Key exclusion criteria 1)With severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease.
2)Psychotic disease
3)Contraindications for MRI examination with gadolinium agent use
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code 606-8507
Address 54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3417
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code 606-8507
Address 54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3417
Homepage URL
Email mizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.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
2020 Year 04 Month 07 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 Enrolling by invitation
Date of protocol fixation
2020 Year 03 Month 10 Day
Date of IRB
2020 Year 03 Month 10 Day
Anticipated trial start date
2020 Year 04 Month 07 Day
Last follow-up date
2024 Year 03 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the efficacy and feasibility of LINAC-based single isocenter stereotactic irradiation

Management information
Registered date
2020 Year 04 Month 07 Day
Last modified on
2020 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045715

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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