UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026856
Receipt number R000028792
Scientific Title Phase 2 study of bevacizumab in a fixed term for glioblastoma
Date of disclosure of the study information 2017/04/04
Last modified on 2017/07/20 09:46:28

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Basic information

Public title

Phase 2 study of bevacizumab in a fixed term for glioblastoma

Acronym

Study of bevacizumab in a fixed term for glioblastoma

Scientific Title

Phase 2 study of bevacizumab in a fixed term for glioblastoma

Scientific Title:Acronym

Study of bevacizumab in a fixed term for glioblastoma

Region

Japan


Condition

Condition

glioblastoma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy and safety of bevacizumab in a fixed term for glioblastoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

progression free survival, time of high KPS

Key secondary outcomes

overall survival, 2-year survival rate, the rae of adverse events, the rate of severe adverse events


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

Medicine

Interventions/Control_1

Radiation therapy (local site, 60Gy, 30 fractions)
Temozolomide (concomitant phase: 75mg/m2, maintenance phase: 150-200mg/m2)
Bevacizumab (10mg/kg, starting at week 4 of radiotherapy, 12 doses)

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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Histologically verified glioblastoma based on WHO classification.
(1) No prior treatment for glioma.
(2) initial glioma
(3) tumor was resected more than 90 % based on postoperative MRI
(4) More than or equal to 50% of tumor must be located in cerebrum or diencephalon.
(5) clinically no metastatic tumors
(6) No multicentric lesions nor dissemination on preoperative MRI.
(7) ECOG PS must be 0-2, and 3 due to neurological symptoms caused by tumor.
(8) Age must be >= 20 and <= 75 years old.
(9) Written informed consent must be provided.
(10)meet the criteria shown below.
The latest results should be adopted.
1) neutrophil count >=1,500/mm3
2) Haemoglobin >=8.0g/dL
3) Platelet count >=10.0*the fourth power of10/mm3
4) AST <=120IU/L
5) ALT <=120IU/L
6) Serum creatinine <=1.5mg/dL
7) Proteinuria <=1+
8) PT-INR <=1.5

Key exclusion criteria

(1) Evidence of recent haemorrhage on postoperative MRI.
(2) Any prior chemotherapy, radiotherapy or immunotherapy (including vaccine therapy) for glioma.
(3) Prior radiotherapy to the brain.
(4) Uncontrolled hypertension (systolic pressure >= 150, diastolic pressure >= 100).
(5)Prior history of hypertensive crisis, or hypertensive encephalopathy.
(6)Congestive heart failure (NYHA class III, or greater)
(7)History of hemoptysis (Grade 2 or higher in CTCAE v4.0) within 1 month.
(8) Coagulopathy
(9) Uncontrolled gastrointestinal ulceration.
(10) Serious or non-healing wound or traumatic bone fracture.
(11) Past history within 6 months, as follows.
Unstable angina, acute myocardial infarction, symptomatic cerebral infarction, arterial or venous thrombosis which required medical treatment, digestive tract perforation or abdominal fistula,intra-abdominal abscess, and intracranial abscess
(12) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
(13) Pregnancy or lactation, as well as fertile women and men unwilling or unable to use effective means of contraception
(14) Allergy to temozolomide, bevacizumab
(15) Patients with allergy to gadolinium.
(16) Patients registering other clinical trial.
(17) Attending physician has determined unsuitable to participate in the study.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Hirose

Organization

Fujita Health University

Division name

Department of Neurosurgery

Zip code


Address

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi

TEL

0562-93-9253

Email

shigeo.ohba@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shigeo Ohba

Organization

Fujita Health University

Division name

Department of Neurosurgery

Zip code


Address

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi

TEL

0562-93-9253

Homepage URL


Email

shigeo.ohba@gmail.com


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

none

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

2017 Year 04 Month 04 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

Open public recruiting

Date of protocol fixation

2016 Year 09 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 03 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

2017 Year 04 Month 04 Day

Last modified on

2017 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028792


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name