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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003984
Receipt No. R000004794
Scientific Title Boron neutron capture therapy combined with X-ray fractionation and temozolomide for newly-diagnosed malignant glioma
Date of disclosure of the study information 2010/08/03
Last modified on 2010/08/02

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Basic information
Public title Boron neutron capture therapy combined with X-ray fractionation and temozolomide for newly-diagnosed malignant glioma
Acronym BNCT combined with X-ray fractionation and TMZ
Scientific Title Boron neutron capture therapy combined with X-ray fractionation and temozolomide for newly-diagnosed malignant glioma
Scientific Title:Acronym BNCT combined with X-ray fractionation and TMZ
Region
Japan

Condition
Condition malignant glioma
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 combined with X-ray fractionation and chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes

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 Boron compound:
Boronophenylalanine(BPA) 250mg/kg, i.v.

Neuroron irradiation:
Maximum point dose for the brain and skin should be less than 13Gy-Eq
X-ray fractionation
40Gy/20fr

temozolomide:
75mg/m2, concomitant use
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)age: 15or older, 80>
2)Karnofski score: 50%or more
3)supratentorial unilateral tumor
4)no deeper than 7cm from the brain surface
5)written informed consent
6)co-operation for follow-up
Key exclusion criteria 1)Dissemination
2)blood analyses
AST,ALT > 100IU/ml , Bilirubin > 2.0mg%
BUN > 30mg/dl , Cr > 1.8mg%
WBC < 2500/mm3 , Plt < 75000/mm3 , Hb < 8g/dl
3)prior radiation
4)double cancer
5)phenylketonuria
6)considerable complications
7)other important condition which is inappropriater for the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Matsumura
Organization University of Tsukuba
Division name Department of Neurosurgery
Zip code
Address Tennodai 1-1-1, Tuskuba, Ibaraki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Yamamoto
Organization University of Tsukuba
Division name Department of Neurosurgery
Zip code
Address
TEL 029-853-3220
Homepage URL
Email

Sponsor
Institute Department of Neurosurgery,Graduate School of Comprehensive Human Science, University of Tsukuba
Institute
Department

Funding Source
Organization Grant from the Ministry of Educaton, Calture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 03 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 Open public recruiting
Date of protocol fixation
2009 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 02 Day
Last modified on
2010 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004794

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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