UMIN-CTR Clinical Trial

Basic information
Public title	research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm
Acronym	radiation therapy for giant and/or thrombosed cerebral aneurysm
Scientific Title	research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm
Scientific Title:Acronym	radiation therapy for giant and/or thrombosed cerebral aneurysm
Region	Japan

Condition
Condition	giant and/or thrombosed cerebral aneurysms that grow after surgical treatment
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of radiation therapy for surgically-treated growing giant and/or thrombosed cerebral aneurysms
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	growth of aneurysm rupture of aneurysm
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Hypofractionated Stereotactic Radiation Therapy 35Gy/5fr.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)unruptured giant and/or thrombosed aneurysms not applicable to direct or endovascular surgery 2)aneurysmal grwoth was confirmed with CT or MRI 3)wrriten informed consent
Key exclusion criteria	1)ruptured aneurysms 2)history of radiation therapy or in radiation therapy for head disease 3)patients associated with stenotic cerebral artery in the vicinity of aneurysm
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Miyamoto
Organization	Kyoto university Graduate School of Medicine
Division name	Neurosurgery
Zip code	606-8507
Address	54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL	075-751-3653
Email	miy@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Kazuimichi Middle name Last name Yoshida
Organization	Kyoto university Graduate School of Medicine
Division name	Neurosurgery
Zip code	606-8507
Address	54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL	075-751-3459
Homepage URL
Email	kazuy@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Neuosurgery, Kyoto university Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
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	Kyoto University Hospital Ethics Committe
Address	54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2012 Year 06 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	Terminated
Date of protocol fixation	2012 Year 04 Month 02 Day
Date of IRB	2012 Year 06 Month 07 Day
Anticipated trial start date	2012 Year 06 Month 07 Day
Last follow-up date	2020 Year 06 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 05 Month 01 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008676