UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on safety and efficacy of the whole brain radiation 20Gy/5 time for the metastatic brain tumor
Title of the study (Brief title)	Study on safety and efficacy of the whole brain radiation 20Gy/5 time
Region	Japan

Condition
Condition	metastatic brain tumor
Classification by specialty	Hematology and clinical oncology Neurology Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safe evaluation of the whole brain radiation 20Gy/5 time
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Having onset of harmful phenomenon or not
Key secondary outcomes	Reduction effect of tumor All survival periods

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	Treatment
Type of intervention	Other
Interventions/Control_1	It enforces whole brain radiation at 4 Gy once a day for five days
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) The existence of the metastatic brain tumor was confirmed by CT or MRI 2) Primary tumor or having a diagnosis of an epithelial tumor (squamous cell carcinoma, adenocarcinoma) pathologically in a metastatic site 3) A vital prognosis is predicted in KPS<70 with 2-3 months 4) Age at the time of the agreement acquisition being more than 20 years old 5) An agreement being provided in a document from the patient about the trial entry
Key exclusion criteria	1) There is a history of the radiotherapy to the head 2) It was taken as the adaptation of localization radiotherapy and the surgical remedy 3) The patient whom physique maintenance is not possible, and radiotherapy cannot enforce 4) Woman with the likelihood of during the pregnancy or the pregnancy 5) The patient who judged it to be inadequate by the judgment of the examination medical attendant
Target sample size	15

Research contact person
Name of lead principal investigator	Akifumi Niiya
Organization	Showa University Hospital
Division name	Radiotherapy department
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8570
Email	cual6_po4_4_oh_8_4h2o@yahoo.co.jp

Public contact
Name of contact person	Akifumi Niiya
Organization	Showa University Hospital
Division name	Radiotherapy department
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8570
Homepage URL
Email	cual6_po4_4_oh_8_4h2o@yahoo.co.jp

Sponsor
Institute	Showa University Hospital radiotherapy department
Institute
Department

Funding Source
Organization	Showa University Hospital radiotherapy department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Juntendo University Urayasu Hospital radiology department
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	昭和大学病院（東京都）、順天堂大学医学部附属浦安病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 07 Day
Anticipated trial start date	2016 Year 01 Month 07 Day
Last follow-up date
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	2016 Year 03 Month 07 Day
Last modified on	2018 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024644