UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027361
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Fujieda Heisei Memorial Hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.