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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034959
Receipt No. R000039863
Scientific Title Study on effectiveness of bevacizumab for treatment of radiation necrosis in the brain caused by gamma knife radiation therapy
Date of disclosure of the study information 2018/11/26
Last modified on 2019/05/27

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Basic information
Public title Study on effectiveness of bevacizumab for treatment of radiation necrosis in the brain caused by gamma knife radiation therapy
Acronym Bevacizumab for brain radiation necrosis
Scientific Title Study on effectiveness of bevacizumab for treatment of radiation necrosis in the brain caused by gamma knife radiation therapy
Scientific Title:Acronym Bevacizumab for brain radiation necrosis
Region
Japan

Condition
Condition Radiation necrosis in the brain
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effectiveness and safety of bevacizumab for treatment of radiation necrosis in the brain caused by gamma knife radiation therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of symptoms and MRI findings 2 years after initial treatment with bevacizumab.
Key secondary outcomes 1)Safety 2)re-exacerbation with 2 years after initial treatment with bevacizumab.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of bevacizumab
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
85 years-old >=
Gender Male and Female
Key inclusion criteria radiation necrosis in the brain caused by gamma knife radiation therapy
Key exclusion criteria Association of contraindication of bevacizumab
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Takao
Middle name
Last name Hashimoto
Organization Aizawa Hospital
Division name Department of Neurology
Zip code 390-8510
Address 3-1-1 Honjo, Matsumoto
TEL 0263338600
Email sinke-dr@ai-hosp.or.jp

Public contact
Name of contact person
1st name Takao
Middle name
Last name Hashimoto
Organization Aizawa Hospital
Division name Department of Neurology
Zip code 390-8510
Address 3-1-1 Honjo, Matsumoto
TEL 0263338600
Homepage URL
Email sinke-dr@ai-hosp.or.jp

Sponsor
Institute Department of Neurology, Aizawa Hospital
Institute
Department

Funding Source
Organization no funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Aizawa Hospital
Address 2-5-1 Honjo, Matsumoto 390-8510
Tel 0263338600
Email sinke-dr@ai-hosp.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 相澤病院(長野県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 02 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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