UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034959 |
|---|---|
| Receipt number | 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 | 2023/05/01 13:47:14 |
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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
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
sinke-dr@ai-hosp.or.jp
Sponsor or person
Institute
Department of Neurology, Aizawa Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 21 | Day |
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
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039863
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
