UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024794 |
|---|---|
| Receipt number | R000028523 |
| Scientific Title | Efficacy of bevacizumab on brain radiation necrosis after irradiation for brain diseases. |
| Date of disclosure of the study information | 2016/11/11 |
| Last modified on | 2020/05/14 10:43:58 |
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Basic information
Public title
Efficacy of bevacizumab on brain radiation necrosis after irradiation for brain diseases.
Acronym
Efficacy of bevacizumab on radiation necrosis
Scientific Title
Efficacy of bevacizumab on brain radiation necrosis after irradiation for brain diseases.
Scientific Title:Acronym
Efficacy of bevacizumab on radiation necrosis
Region
| Japan |
Condition
Condition
brain radiation necrosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to elucidate treatment efficacy of short-scheduled bevacizumab on radiation necrosis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
duration of remission in brain edema
Key secondary outcomes
1) frequency and severity of adverse events related to short-scheduled bevacizumab
2) treatment efficacy of rechallenge of bevacizumab on radiation necrosis after relapse
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bevacizumab of 5mg/kg was administered every other week, 3 cycles in total.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were suspected radiation necrosis on a basis of MRI and/or PET.
Patients underwent brain irradiation for brain diseases.
Patients had any symptoms.
Key exclusion criteria
Patients had hemorrhagic diseases.
Patients had allergy for bevacizumab.
Patients were suspected tumor recurrence.
Pregnant patients.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motomasa |
| Middle name | |
| Last name | Furuse |
Organization
Osaka Medical College
Division name
Neurosurgery
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
neu054@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Motomasa |
| Middle name | |
| Last name | Furuse |
Organization
Osaka Medical College
Division name
Neurosurgery
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
neu054@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
none
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
institutional review board of the Osaka Medical College
Address
2-7, Daigakumachi, Takatsuki, Osaka
Tel
072-683-1221
rinri@osaka-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028523
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| Registered date | File name |
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| Registered date | File name |
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