UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to brain metastases using intensity modulated radiotherapy
Title of the study (Brief title)	BM HA-SIB-IMRT P2
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the efficacy and safety of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to 1-10 brain metastases using intensity modulated radiotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Intracranial progression-free survival
Key secondary outcomes	Tumor response, Local progression-free survival, Intracranial new lesion-free survival, Morbidity, Time to deterioration of neurocognitive function, Overall survival

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	Device,equipment
Interventions/Control_1	A total dose of 30Gy is delivered in 15 fractions to whole brain, whereas 63Gy is delivered simultaneously to brain metastases. The maximum dose to bilateral hippocampus should be limited to <15Gy.
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) Pathologically or clinically diagnosed primary malignant solid tumor 2) No history of radiotherapy for brain metastasis 3) No indication for surgical resection for brain metastasis 4) 1 to 10 brain metastases diagnosed by Gd-enhanced MRI 5) Maximum tumor diameter <3.5cm & the next largest tumor <3cm & other tumor diameters <1cm 6) KPS (karmofsky Performance Status) = or <70 7) Written informed consent
Key exclusion criteria	1) The distance of hippocampus to metastatic brain tumor < 1.5cm 2) Unknown primary site 3) Primary tumor histology of small cell lung cancer, lymphoma or other blood tumor 4) Radiologically or clinically suspected carcinomatous meningitis 5) With critical comorbidity 6) Allergy to Gd contrast medium 7) In pregnancy or with expectation of pregnancy
Target sample size	54

Research contact person
Name of lead principal investigator	Jun Itami
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Division of Radiation Oncology
Address	5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL	03-3542-2511
Email	jitami@ncc.go.jp

Public contact
Name of contact person	Koji Inaba
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Division of Radiation Oncology
Address	5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	koji_i_14@yahoo.co.jp

Sponsor
Institute	Division of Radiation Oncology and division of Neurooncology, National Cancer Center Hospital, Tokyo, Japan
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)

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	国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 08 Month 07 Day
Anticipated trial start date	2013 Year 03 Month 12 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	2019 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 12 Day
Last modified on	2018 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011973