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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002385
Receipt No. R000002932
Scientific Title A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy
Date of disclosure of the study information 2009/09/01
Last modified on 2018/03/14

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Basic information
Public title A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy
Acronym BNCT, XRT plus chemotherapy for newly diagnosed GBM
Scientific Title A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy
Scientific Title:Acronym BNCT, XRT plus chemotherapy for newly diagnosed GBM
Region
Japan

Condition
Condition Newly-diagnosed glioblastoma
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase II, multicenter, study for newly diagnosed GBs using BNCT, additional 24 Gy XRT with 3 gradient and concomitant and adjuvant chemotherapy with TMZ is conducted to evaluate overall survival as primary endpoint and tumor response and adverse effects as secondary endpoints
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival (OS)
Key secondary outcomes Tumor response
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 24 Gy XRT and chemotherapy with TMZ. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional XRT is given with 3 gradient such as 8, 16, 24 Gy from the surface of scalp to the bottom of tumor. Chemotherapy with TMZ is applied concomitantly during XRT treatments and adjuvant chemotherapy with the same agent is repeated in outpatient clinic.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with definitive newly diagnosed GB by histopathology.
2) The tumor locates at a supra-tentorial hemisphere.
3) 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.
4) KPS is 60% or more.
5) Life expectancy is more than 3 months.
6) Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.
a) Leukocyte count is more than 3,000/microlitter
b) Hemoglobin level is more than 8.0 g/deciliter
c) Platelet count is more than 100000 / microlitter
d) Serum creatine level is more than 1.5 mg/ deciliter
e) ALT levels is more than 100 IU/litter
f) AST levels is more than 100 IU/litter
7) Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation.

Key exclusion criteria 1) Patients who have been treated with chemotherapy or radiotherapy.
2) Female patients in definitive or possible pregnancy or in breast-feeding.
3) Patients with phenylketonuria.
4) Patients with grade III or IV in NYHA classification.
5) Patients with cerebrospinal fluid dissemination.
6) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.

Target sample size 45

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

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 Grant from the Ministry of Health and Labor
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Translational Research Center
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
2009 Year 09 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 Completed
Date of protocol fixation
2009 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2016 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 26 Day
Last modified on
2018 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=R000002932

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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