UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/IIa clinical trial of Boron neutron Capture Therapy for the patients with recurrent malignant brain tumor
Acronym	Phase I/IIa clinical trial of Boron neutron Capture Therapy for the patients with recurrent malignant brain tumor
Scientific Title	Phase I/IIa clinical trial of Boron neutron Capture Therapy for the patients with recurrent malignant brain tumor
Scientific Title:Acronym	Phase I/IIa clinical trial of Boron neutron Capture Therapy for the patients with recurrent malignant brain tumor
Region	Japan

Condition
Condition	Recurrent malignant brain tumor
Classification by specialty	Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the safety and effectiveness of the boron neutron capture therapy for recurrent malignant brain tumor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety Overall survival
Key secondary outcomes	Progression free survival Tumor control rate, local control rate QOL, neurological function

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	Medicine Device,equipment
Interventions/Control_1	1)Boron compounds 250mg/kg of boronopehnylalanine, dose escalation was possible 2)Neutron irradiation Less than 12Gy-Eq for normal brain and skin dose.
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	15 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Agaed 15 and over, and 70 and under. Diagnosed as recurrent malignant glioma, recurrent malignant /anaplastic meningioma, malignant melanoma, and metastatic brain tumor or skull base tumor with no standard therapies. 2) Karnofsky Performance Scale(KPS) >50% 3) Enhance lesion locate within cerebral hemisphere. Infratentorial lesions without untreated hydrocephalus or brain stem compression. 4) The target lesion is located within 7cm from the brain surface. 5) Informed about their diagnosis. 6) course observation is possible.
Key exclusion criteria	1)Patient with dissemination. 2)AST,ALT > 100IU/ml , Bilirubin > 2.0mg% BUN > 30mg/dl , Cr > 1.8mg% WBC < 2500/mm3 , Plt < 75000/mm3 , Hb < 8g/dl 3)irradiated > 70Gy-Eq to the lesion or normal brain tissue as a previous treatment. 4)There are other malignanicies. 5)The patients with phenylcetonuria. 6)Patients who have complications that are considered inappropriate for the trial. 7)Responsible doctors judged the patient inappropriate for the trial.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Matsumura
Organization	Institute of Clinical Medicine Graduate School of Comprehensive Human Sciences University of Tsukuba
Division name	Department of Neurosurgery
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Japan
TEL	+81-298-53-3220
Email

Public contact
Name of contact person	1st name Middle name Last name Kei Nakai
Organization	Institute of Clinical Medicine Graduate School of Comprehensive Human Sciences University of Tsukuba
Division name	Department of Neurosurgery
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Japan
TEL	+81-298-53-3220
Homepage URL
Email	knakai@md.tsukuba.ac.jp

Sponsor
Institute	Department of Neurosurgery Institute of Clinical Medicine Graduate School of Comprehensive Human Sciences University of Tsukuba
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2010 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	2010 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2015 Year 06 Month 01 Day
Date of closure to data entry	2015 Year 06 Month 01 Day
Date trial data considered complete	2015 Year 06 Month 01 Day
Date analysis concluded	2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 01 Day
Last modified on	2012 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004472

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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