UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003984 |
|---|---|
| Receipt number | 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 22:13:21 |
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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
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
Sponsor or person
Institute
Department of Neurosurgery,Graduate School of Comprehensive Human Science, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004794
