UMIN-CTR Clinical Trial

Basic information
Public title	Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Acronym	Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Scientific Title	Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Scientific Title:Acronym	Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Region	Japan

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

Objectives
Narrative objectives1	To investigate the feasibility of low-dose whole brain radiotherapy (25 Gy in 10 fractions) combined with stereotactic irradiation for 1-4 brain metastatic patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Development rate of distant brain metastases at 6-month after treatment
Key secondary outcomes	1) Neurocognitive function at 4-month 2) Neurocognitive function at 12-month 3) Local tumor control of brain metastases 4) Overall survival 5) Cause of death

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	Maneuver
Interventions/Control_1	Low-dose whole brain radiotherapy (25 Gy in 10 fractions)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age: 20-80 years old 2) Systemic status: KPS >= 70 3) Histopathologically confirmed 3) Indication for stereotactic irradiation (number of brain metastases, 4 or less, maximum tumor diameter, 3 cm of less) 5) Consent to neurocognitive fuctional tests and QOL questionnaire 6) Consent to this study
Key exclusion criteria	1) severe decline in neurocognitive function or language ability at baseline 2) history of brain radiation therapy 3) history of brain surgery of brain metastases 4) small cell carcinoma, germinoma, lymphoma 5) any other reasons not to fit to this study
Target sample size	70

Research contact person
Last name of lead principal investigator	1st name Hidefumi Middle name Last name Aoyama
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Radiology
Zip code	9518510
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata, 9518510
TEL	025-227-2315
Email	jrosg13-1@med.niigata-u.ac.jp

Public contact
1st name of contact person	1st name Hidefumi Middle name Last name Aoyama
Organization	Niigata Univerisity Graduate School of Medical and Dental Sciences
Division name	Radiology
Zip code	9518510
Address	1-757 Asahimachi-dori, Chuo-ku, 9518510
TEL	025-227-2315
Homepage URL	http://www.jrosg.jp/protocol/protocol_list.html
Email	jrosg13-1@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University, Dept of Radiology, Japanese Radiation Oncology Study Group
Institute
Department

Funding Source
Organization	JSJP Niigata University Funding for Support for Clinical Study
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Niigata University Hospital
Address	1-754 Asahimachi-dori, Niigata
Tel	025-227-0730
Email	smaru@dent.niigata-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	JROSG 13-1
Org. issuing International ID_1	Japanese Radiation Oncology Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	新潟大学医歯学総合研究科（新潟県）、県立がんセンター新潟病院（新潟県）、琉球大学附属病院（沖縄県）、埼玉県立がんセンター（埼玉県）、国立がん研究センター中央病院（東京）、熊本大学、北海道大学（北海道）、北海道がんセンター（北海道）

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 09 Day

Related information
URL releasing protocol	http://www.jrosg.jp/protocol/file/JROSG13-1_20150630-2.pdf
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	No longer recruiting
Date of protocol fixation	2012 Year 03 Month 28 Day
Date of IRB	2012 Year 03 Month 28 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 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 10 Month 06 Day
Last modified on	2019 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010628