UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002385 |
|---|---|
| Receipt number | 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 15:06:50 |
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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
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
neu070@poh.osaka-med.ac.jp
Sponsor or person
Institute
Dept. of Neurosurgery, Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002932
