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

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 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

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

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