UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of bevacizumab in a fixed term for glioblastoma
Title of the study (Brief title)	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	Yuichi Hirose
Organization	Fujita Health University
Division name	Department of Neurosurgery
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
TEL	0562-93-9253
Email	shigeo.ohba@gmail.com

Public contact
Name of contact person	Shigeo Ohba
Organization	Fujita Health University
Division name	Department of Neurosurgery
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
TEL	0562-93-9253
Homepage URL
Email	shigeo.ohba@gmail.com

Sponsor
Institute	Fujita Health University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028792