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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027490
Receipt No. R000031449
Scientific Title retrospective study of gamma knife radiosurgery for brain metastases of small cell lung carcinoma after whole brain radiotherapy
Date of disclosure of the study information 2017/06/30
Last modified on 2019/05/27

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Basic information
Public title retrospective study of gamma knife radiosurgery for brain metastases of small cell lung carcinoma after whole brain radiotherapy
Acronym JLGK1701 study
Scientific Title retrospective study of gamma knife radiosurgery for brain metastases of small cell lung carcinoma after whole brain radiotherapy
Scientific Title:Acronym JLGK1701 study
Region
Japan

Condition
Condition brain metastases of small cell lung carcinoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluation of gamma knife radiosurgery for brain metastases of small cell lung carcinoma after whole brain radiotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival, local control, new lesion free survival, functional preservaton, neurological death, side effect
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 all of uncontrolled brain metastases of small cell lung carcinoma after whole brain radiotherapy were treated with first and single session gamma knife radiosurgery
Key exclusion criteria 1 gamma knife radiosurgery before whole brain radiotherapy
2 presence of leptomeningeal dissemination
3 surgery for brain metastases before gamma knife radiosurgery
4 intracranial metastases outside of brain
5 Karnofsky performance status <70 or no expectation for improvement of KPS >60 after gamma knife radiosurgery
6 gamma knife radiosurgery without gadlinium enhancement MRI
7 the number of brain metastases >10 or the total volume of brain metastases >15ml or the volume of maximum brain metastasis >10ml
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Nakazaki
Organization Brain Attack Center Ota Memorial Hospital
Division name neurosurgery
Zip code 720-0825
Address 3-6-28 Okinogami, Fukuyama, Hiroshima
TEL 084-931-8650
Email nakazaki@shouwa.or.jp

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Nakazaki
Organization BraiIn Attack Center Ota Memorial Hospital
Division name neurosurgery
Zip code 720-0825
Address 3-6-28 Okinogami, Fukuyama, Hiroshima
TEL 084-931-8650
Homepage URL
Email nakazaki@shouwa.or.jp

Sponsor
Institute Japan Leksell Gamma Knife Society
Institute
Department

Funding Source
Organization Brain Attack Center Ota Memorial Hospital
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 Ota memorial hospital
Address 3-6-28 Okinogami, Fukuyama
Tel 084-931-8650
Email nakazaki@shouwa.or.j@

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
2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2017 Year 04 Month 30 Day
Date of IRB
2017 Year 04 Month 18 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1 ages,sex
2 history of primary cancer, the type of WBRT: PCI or not PCI, presence of brain images before WBRT, dose of WBRT, dose of boost, leukoencephalopathy: grade1 little or no white matter hyperintensity; grade2 limited periventricular hyper intensity; grade3 diffuse white matter hyperintensity
3 each duration and other characteristics
duration between primay cancer diagnosis and WBRT, duration between praimary cance diagnosis and GKRS, duration between last day of WBRT and GKRS, duration between brain metatases diagnosis and GKRS
KPS score, cause of deterioration of KPS, control of primary cancer, presence of extracranial metastases
4 symptoms of brain metastases at GKRS
charactaristics of images: number of brain metastases including lesions controlled after WBRT, number of brain metastases, volume and maximum diameter of maximum lesion treated with GKRS, total volume of brain metastases treated with GKRS, presence of edema, leukoencephalopathy, TSID
5 volume and prescribed dose of each lesions at GKRS, maximum dose per case
6 outcome of brain metastases
presence of Gd enhanced MRI, duration between GKRS and Gd enhanced MRI, local control per cases(contorol failure: the tumor size of lesion tereated >120% of maximum diameter at GKS), duration between GKRS and control failure, presense of perifocal edema, duration between GKRS and deterioration of edema, progression of leukoencephalopathy, duration between GKRS and pregoression of leukoencephalopathy, grade of leukoencephalopathy at the last follow up MRI, appearance of new lesions, duration between GKRS and appearance of new lesions, appearance of leptomenigeal dissemination, duration between GKRS and appearance of leptomeningeal dissemination, outcome of symptom of brain metastases, side effect (RTOG grade), salvage treatment: GKRS, WBRT, surgery, chemotherapy
7 other outcome
overall survival, causes of death, functional preservation, cause of deterioration of ADL
8 other information

Management information
Registered date
2017 Year 05 Month 25 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031449

Research Plan
Registered date File name
2019/05/27 edJLGK申請プロトコール 2017 4 22.doc

Research case data specifications
Registered date File name
2019/05/27 添付2 JLGK登録票 2017 4 6.doc

Research case data
Registered date File name
2019/05/27 JLGK1701 data of patints included.xlsx


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