UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027361
Receipt number R000031356
Scientific Title Low-dose gamma knife radiosurgery plus whole-brain radiation therapy for multiple brain metastases: a multi-institutional prospective study
Date of disclosure of the study information 2017/05/17
Last modified on 2019/03/24 21:50:58

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Basic information

Public title

Low-dose gamma knife radiosurgery plus whole-brain radiation therapy for multiple brain metastases: a multi-institutional prospective study

Acronym

Low-dose gamma knife radiosurgery plus whole-brain radiation therapy for multiple brain metastases: a multi-institutional prospective study

Scientific Title

Low-dose gamma knife radiosurgery plus whole-brain radiation therapy for multiple brain metastases: a multi-institutional prospective study

Scientific Title:Acronym

Low-dose gamma knife radiosurgery plus whole-brain radiation therapy for multiple brain metastases: a multi-institutional prospective study

Region

Japan


Condition

Condition

Metastatic brain tumors

Classification by specialty

Radiology Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate the early response, efficacy and toxicity of low-dose GK plus WBRT for multiple (including 10 or more) BMs and large BMs over 3 cm with or without meningeal dissemination.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Over all survival

Key secondary outcomes

The cumulative incidence of intracranial recurrence, adverse event


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Perform low-dose GK plus WBRT for multiple
(including 10 or more) BMs and large BMs over 3 cm with or without meningeal dissemination

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Either a,b or c
(a)10 or more BMs
(b)Tumor diameter > 3, < 4 cm)
(c)BMs with meningeal dissemination
(2)Karnofsky Performance Status (KPS) score>=70 KPS<70 due to neurological symptom
(3)No history of cranial radiation therapy or craniotomy

Key exclusion criteria

(1)Active double cancer
(2)In pregnancy or lactation period
(3)Psychiatric disorder
(4)Allergy to gadolinium contrast or contraindication of MR imaging

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akifumi
Middle name
Last name Miyakawa

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Radiology

Zip code

4670001

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan

TEL

052-853-8274

Email

amiyakawa21@triton.ocn.ne.jp


Public contact

Name of contact person

1st name Akifumi
Middle name
Last name Miyakawa

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Radiology

Zip code

4670001

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan

TEL

052-853-8274

Homepage URL


Email

amiyakawa21@triton.ocn.ne.jp


Sponsor or person

Institute

Fujieda Heisei Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tsukiji Neurological Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fujieda-Heisei Memorial Hospital

Address

123-1, Mizukami, Fujieda city

Tel

054-643-1230

Email

heisei.msw.room@ny.tokai.or.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

藤枝平成記念病院(静岡県)
築地神経科クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 17 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s10147-018-1339-7?wt_mc=Internal.Event.1.SEM.ArticleAuthor

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s10147-018-1339-7?wt_mc=Internal.Event.1.SEM.ArticleAuthor

Number of participants that the trial has enrolled

40

Results

After GK plus WBRT for 40 patients, 31 did not develop further intracranial recurrence until death or last follow-up, whereas 9 developed recurrence. With a follow-up period up to 24 months, the overall survival rate was 36% at 12 months and median survival time was 8 months. The cumulative incidence of intracranial recurrence was 25% at 12 months.

Results date posted

2019 Year 03 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 08 Month 11 Day

Baseline Characteristics

1. >?5 BM with or without meningeal dissemination and 2. the largest tumor diameter < 4 cm. During 2013-2016, 40 patients (13 men and 27 women) entered the study. Nineteen had meningeal dissemination. The GK dose was 12 Gy at the periphery when the longest diameter was 3-4 cm and 14 Gy when it was <?3 cm. The WBRT dose to the isocenter was 30 Gy in 10 fractions, or 37.5 Gy in 15 fractions for two patients.

Participant flow

During 2013-2016, 40 patients (13 men and 27 women) entered the study. Nineteen had meningeal dissemination.

Adverse events

Two patients had symptomatic brain edema, but it was controlled by corticosteroids. One patient had leukoencephalopathy. One patient had radiation necrosis after radiotherapy. Two patients had middle ear inflammation, but it was controlled by surgical treatment.

Outcome measures

After GK plus WBRT for 40 patients, 31 did not develop further intracranial recurrence until death or last follow-up, whereas 9 developed recurrence. With a follow-up period up to 24 months, the overall survival rate was 36% at 12 months and median survival time was 8 months. The cumulative incidence of intracranial recurrence was 25% at 12 months.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2014 Year 06 Month 01 Day

Date of IRB

2014 Year 06 Month 05 Day

Anticipated trial start date

2014 Year 06 Month 07 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 06 Month 30 Day

Date trial data considered complete

2017 Year 07 Month 31 Day

Date analysis concluded

2017 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 05 Month 16 Day

Last modified on

2019 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name