UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003692 |
|---|---|
| Receipt number | R000004472 |
| Scientific Title | Phase I/IIa clinical trial of Boron neutron Capture Therapy for the patients with recurrent malignant brain tumor |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2012/06/26 09:46:13 |
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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
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
knakai@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Neurosurgery
Institute of Clinical Medicine
Graduate School of Comprehensive Human Sciences
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004472
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