UMIN-CTR Clinical Trial

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