UMIN-CTR Clinical Trial

Basic information
Public title	Hypofractionated stereotactic radiotherapy for large brain metastases
Acronym	Hypofractionated stereotactic radiotherapy for large brain metastases
Scientific Title	Hypofractionated stereotactic radiotherapy for large brain metastases
Scientific Title:Acronym	Hypofractionated stereotactic radiotherapy for large brain metastases
Region	Japan

Condition
Condition	Brain metastases
Classification by specialty	Radiology Neurosurgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and toxicity about hypofractionated stereotactic radiotherapy against large brain metastases using Cyberkife.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival rate at 6 months
Key secondary outcomes	1) Performance status and activity of daily living at 3, 6 and 12 months 2) Toxicity 3) Local control rate at 6 and 12 months 4) Occurrence of new brain metastases 6 and 12 months

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 Other
Interventions/Control_1	Hypofractionated stereotactic radiotherapy using CyberKnife depending on the tumor volume.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) One to four brain metastases with a maximum diameter of 2 cm or more for the largest lesion on contrast enhanced magnetic resonance imagings. 2) Unfit to craniotomy. 3) All brain metastases do not locate near the brain stem, optic nerve or chiasma. 4) Systematic status; Karnofsky Performance Status >= 70. 5) Oxygen saturation >= 96% in room air. 6) Consent to this study.
Key exclusion criteria	1) Patient with dissemination. 2) There are other malignanicies. 3) Patients in pregnancy. 4) Unknown primary cancer 5) Patient with schizoaffective disorder or other severe psychiatric disorder. 6) Patients treated with steroid for one or more months. 7) Brain metastases of malignant melanoma, sarcoma, lymphoma or small cell lung cancer. 8) Responsible doctors judged the patient inappropriate for the trial. 9) No history of craniotomy or radiotherapy to the brain
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Murai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
Zip code	467-8602
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL	052-853-8274
Email	tmurai-ngi@umin.ac.jp

Public contact
Name of contact person	1st name Taro Middle name Last name Murai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
Zip code	467-8602
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL	052-853-8274
Homepage URL
Email	taro8864@yahoo.co.jp

Sponsor
Institute	Department of Radiology, Nagoya City University Graduate School of Medical Sciences
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	Shin-ryoku Neurosurgery
Address	Ichizawa-cho 574-1, Asahi-ku, Yokohama
Tel	045-355-3600
Email	cyber@syck.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	横浜サイバーナイフセンター（神奈川県）、日赤医療センター（東京都）、つくばセントラル病院（茨城県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 25 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 11 Month 25 Day
Date of IRB	2012 Year 11 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2023 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 02 Month 25 Day
Last modified on	2021 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011848