UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058644 |
|---|---|
| Receipt number | R000067026 |
| Scientific Title | A Multicenter Retrospective Study Comparing Radiosurgical Techniques for Large Brain Metastases Treated with Gamma Knife Radiosurgery (Japanese Leksell Gamma Knife Society 2501 Study) |
| Date of disclosure of the study information | 2025/08/04 |
| Last modified on | 2025/07/30 12:27:43 |
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Basic information
Public title
A Multicenter Retrospective Study Comparing Radiosurgical Techniques for Large Brain Metastases Treated with Gamma Knife Radiosurgery (Japanese Leksell Gamma Knife Society 2501 Study)
Acronym
JLGK2501
Scientific Title
A Multicenter Retrospective Study Comparing Radiosurgical Techniques for Large Brain Metastases Treated with Gamma Knife Radiosurgery (Japanese Leksell Gamma Knife Society 2501 Study)
Scientific Title:Acronym
JLGK2501
Region
| Japan |
Condition
Condition
brain metastases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To improve treatment outcomes for large brain metastases, two- or three-stage radiosurgery - administered with inter-fraction intervals of several weeks - has been employed as an alternative to conventional single-session gamma knife radiosurgery. In recent years, technological advancements have enabled the implementation of consecutive fractionated radiosurgery at many gamma knife centers. However, robust evidence regarding its efficacy and safety remains limited. The present study aims to retrospectively analyze a cohort of domestic cases to evaluate the validity of fractionated radiosurgery in terms of both efficacy and safety, primarily through comparison with two- or three-stage radiosurgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CNS index lesion progression-free survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent gamma knife radiosurgery for brain metastases with a tumor volume of 4 cm3 or more between January 1, 2016, and December 31, 2024, will be included
Key exclusion criteria
The patient has previously undergone other treatments or interventions for brain metastases, such as surgical resection, cyst drainage, or whole-brain radiotherapy.
Karnofsky Performance Status (KPS) is below 70% (if neurological symptoms caused by brain metastases are present, the pre-symptom KPS is below 70%).
The number of brain metastases exceeds 10.
Contrast-enhanced MRI was not obtained for treatment planning.
There is evidence of cerebrospinal fluid dissemination.
No post-treatment contrast-enhanced MRI has been obtained, or post-treatment imaging status is unknown.
The primary tumor is classified as carcinoma of unknown origin, sarcoma, or lymphoma.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Kawashima |
Organization
NTT Medical Center Tokyo
Division name
Gamma Knife Center
Zip code
1418625
Address
5-9-22 Higashi Gotanda, Shinagaga-ku, Tokyo
TEL
0334486111
mariko.furi@gmail.com
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kawashima |
Organization
NTT Medical Center Tokyo
Division name
Gamma Knife Center
Zip code
1420043
Address
5-9-22 Higashi Gotanda, Shinagaga-ku, Tokyo
TEL
0334486111
Homepage URL
mariko.furi@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NTT Medical Center Tokyo Ethical Review Board
Address
5-9-22 Higashi Gotanda, Shinagaga-ku, Tokyo
Tel
0334486111
nmc_soumu-ml@east.ntt.co.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
東京都
Institutions
Institutions
NTT東日本関東病院（東京都）、古川星陵病院（宮城県）、高島病院 （鳥取県）、総合南東北病院（福島県）、小牧市民病院（愛知県）、大田記念病院（広島県）、築地神経科クリニック（東京都）、弘前大学（青森県）、横浜労災病院（神奈川県）、新須磨病院（兵庫県）、千葉県循環器病センター（千葉県）、獨協医科大学病院（栃木県）、中村記念病院（北海道）、東京女子医科大学病院（東京都）、名古屋共立病院（愛知県）、東京大学病院（東京都）、湖東記念病院（滋賀県）、浅ノ川総合病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 04 | 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
| 2025 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multi-institutional, retrospective observational study without any intervention or invasiveness, involving patients who underwent Gamma Knife treatment for brain metastases with a tumor volume of 4 cm3 or larger between January 1, 2016, and December 31, 2024.
The primary endpoint is the local control rate of the main lesion. Secondary endpoints include overall survival, incidence of central nervous system death, lesion-specific local control, intracranial progression-free survival, functional outcomes, and the incidence of radiation necrosis or grade 3 or higher adverse events.
Anonymized clinical, treatment, and follow-up data will be collected in electronic format from each participating institution and analyzed.
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067026
