UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006017 |
|---|---|
| Receipt number | R000007121 |
| Scientific Title | Proton beams radiotherapy for cerebral arteriovenous malformations |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2018/01/24 09:30:16 |
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Basic information
Public title
Proton beams radiotherapy for cerebral arteriovenous malformations
Acronym
AVM-Proton
Scientific Title
Proton beams radiotherapy for cerebral arteriovenous malformations
Scientific Title:Acronym
AVM-Proton
Region
| Japan |
Condition
Condition
Cerebral Arteriovenous Malformation
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety and efficacy of fractionated proton beams radiotherapy for cerebral arteriovenous malformations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Efficacy
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
fractionated proton radiotherapy
Either 36GyE/6frac or 45GyE/15frac is prescribed depending on size and location of AVM
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
| 1 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The major axis of the nidus is 2.5cm or more, or the volume of the nidus is 10cc or more.
2) Surgical extirpation, interventional radiology or stereotactic radiosurgery are not indicated.
3) A period of 1 month or more has passed since the last surgery or interventional radiology.
3) Karnofsky performance scale is 70% or more.
4) Age is 75 years old or less.
5) The patient is well informed of the diagnosis and is able to tell his or her own will.
Key exclusion criteria
1) History of radiotherapy to the same site.
2) The nidus is in contact with the optic nerve or chiasma.
3) Presence of severe intracranial hypertension due to cerebral hemorrhagy or edema.
4) Presence of severe medical complications which make the protocol impossible.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Tsuboi |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Proton medical research center
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-7100
tsuboi@pmrc.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Clinical trial and research center |
Organization
University of Tsukuba
Division name
Clinical trial and research center
Zip code
Address
2-1-1, Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
029-853-7100
Homepage URL
rinshokenkyu@un.tsukuba.ac.jp
Sponsor or person
Institute
Proton Medical Research Center, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 09 | Month | 01 | 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
| 2009 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 14 | 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
| 2011 | Year | 07 | Month | 21 | Day |
Last modified on
| 2018 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007121
