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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013419
Receipt No. R000015651
Scientific Title Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab
Date of disclosure of the study information 2014/03/14
Last modified on 2014/03/14

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Basic information
Public title Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab
Acronym BNCT plus bevacizumab for recurrent malignant gliomas
Scientific Title Clinical trial for recurrent malignant gliomas using boron neutron capture therapy and bevacizumab
Scientific Title:Acronym BNCT plus bevacizumab for recurrent malignant gliomas
Region
Japan

Condition
Condition recurrent malignant glioma
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase I, II, clinical trial for high-risk recurrent malignant gliomas (RPA class 3+7) using boron neutron capture therapy and bevacizumab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Tumor response
Incidence of radiation necrosis and/or pseudoprogression

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
Maneuver
Interventions/Control_1 Protocol treatments consist of BNCT, additional and chemotherapy with bevacizumab. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional bevacizumab is given biweekly with 10mg/kg as long as progressive disease judged by RANO criteria.
Here: RPA class 3 is non-GBM as initial histology and poor KPS less than 70%. RPA class 7 is GBM as initial histology, age more than 50 and steroids required to maintain ADL. The MST of these classes is reported as 4.4 months after the recurrence.
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
10 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1 Patients with definitive diagnosis of recurrent malignant gliomas by histopathology
2 Highly suspect of recurrent malignant glioma on MRI and amino-acid PET
(At least 1 or 2 should be fulfilled.)
3 RPA class 3 : non-GBM as initial histology and poor KPS less than 70%.
4 RPA class 7 : GBM as initial histology, age more than 50 and steroids required to maintain ADL
(candidate should belong to 3 or 4)

5 The tumor locates at a supra-tentorial hemisphere.
The deepest part of the tumor should be less than 6 cm from the scalp. Even if the bottom of the tumor is more than 6 cm from the scalp, the patients may be included in the study, if the air instillation into tumor-removed cavity is possible.

6 Life expectancy is more than 3 months.
7 Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.
a) Leukocyte count more than 3,000 /microL
b) Hemoglobin level more than 8.0 g/dL
c) Platelet countmore than 10.0 x 104 /microL
d) Serum creatine levelless than 1.5 mg/dL
e) ALT levels less than 100 IU/L
f) AST levels less than 100 IU/L
8 Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation.
Key exclusion criteria 1) Female patients in definitive or possible pregnancy or in breast-feeding.
2) Patients with phenylketonuria.
3) Patients with grade 3 or 4 in NYHA classification.
4) Patients with cerebrospinal fluid dissemination.
5) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Department of Neurosurgery
Zip code
Address Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686
TEL 072-683-1221
Email neu070@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-Ichi Miyatake
Organization Osaka Medical College
Division name Department of Neurosurgery
Zip code
Address Daigaku-Machi, 2-7, Takatsuki, Osaka 569-8686
TEL 072-683-1221
Homepage URL
Email neu070@poh.osaka-med.ac.jp

Sponsor
Institute Dept. of Neurosurgery, Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 03 Month 14 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 Preinitiation
Date of protocol fixation
2014 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 20 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
2014 Year 03 Month 14 Day
Last modified on
2014 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015651

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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