UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040093 |
|---|---|
| Receipt number | 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 16:08:28 |
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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
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
mizo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045715
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
