UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027490 |
|---|---|
| Receipt number | 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 | 2020/12/22 10:36:03 |
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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
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
nakazaki@shouwa.or.jp
Sponsor or person
Institute
Japan Leksell Gamma Knife Society
Institute
Department
Personal name
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
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
https://link.springer.com/article/10.1007/s11060-020-03397-9
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11060-020-03397-9
Number of participants that the trial has enrolled
163
Results
The median OS was 9.3 months and the neurologic mortality was 20.0%. Local control failure and new lesion appearance were 36.6% and 64.9%. A BM diameter > 1.0 cm was a significant risk factor for local progression and neurologic death. The symptom improvement was 61.3% and neurological function was preserved for 7.6 months. Therapeutic WBRT was not a significant risk factor for OS, neurological death, local control, or functional deterioration. Symptomatic ARE were 7.4%
Results date posted
| 2020 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1-10 active BMs post-WBRT; the largest brain metastasis was <= 3.0 cm in maximum diameter and < 10.0 mL in volume; no magnetic resonance imaging findings of leptomeningeal dissemination; cumulative tumor volume <= 15.0 mL and; Karnofsky performance status score >= 70 or anticipated favorable neurological function improvement with GKS in patients with KPS scores < 70.
Participant flow
The medical records of 184 patients with active BM arising from SCLC who received GKS following WBRT before October 2016 were obtained from 15 institutions, retrospectively. Twenty one patients were excluded because their follow-up data after GKS were unavailable.
Adverse events
Twelve patients (7.4%) experienced symptomatic AREs. RTOG grade 1, 3, and 4 toxicities occurred in 1, 9, and 2 patients, respectively.
Outcome measures
The primary endpoint was OS. Secondary endpoints included neurologic death, local control, new lesion appearance, progression-free survival, deterioration of leukoencephalopathy, functional preservation, and symptomatic adverse radiation effects .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/31449
