UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Proton beams radiotherapy for cerebral arteriovenous malformations
Title of the study (Brief title)	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	Koji Tsuboi
Organization	University of Tsukuba
Division name	Faculty of Medicine, Proton medical research center
Address	1-1-1, Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL	029-853-7100
Email	tsuboi@pmrc.tsukuba.ac.jp

Public contact
Name of contact person	Clinical trial and research center
Organization	University of Tsukuba
Division name	Clinical trial and research center
Address	2-1-1, Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL	029-853-7100
Homepage URL
Email	rinshokenkyu@un.tsukuba.ac.jp

Sponsor
Institute	Proton Medical Research Center, University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2009 Year 01 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007121