UMIN-CTR Clinical Trial

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

Newly-diagnosed glioblastoma

Classification by specialty

Radiology

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall survival (OS)

Key secondary outcomes

Tumor response
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Adverse event

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Dept. of Neurosurgery, Osaka Medical College

Institute

Department

Personal name

Organization

Grant from the Ministry of Health and Labor

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Translational Research Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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