UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy
Title of the study (Brief title)	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	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Department of Neurosurgery
Address	Daigaku-Machi, 2-7, Takatsuki,Osaka 569-8686
TEL	072-683-1221
Email

Public contact
Name of contact person	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Department of Neurosurgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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