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
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
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
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
