UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bevacizumab for recurrent or refractory malignant glioma
Title of the study (Brief title)	Bevacizumab for recurrent or refractory malignant glioma
Region	Japan

Condition
Condition	Recurrent or recurrent malignant glioma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of Bebacizumab for recurrent and refractory malignant glioma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall survival
Key secondary outcomes	response rate, 6 month progression free survival, 6 month overall survival, safetiness

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Bevacizumab
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)recurrent malignant glioma 2)>= 20 years old, KPS >=60 3)recurrence after TMZ or ACNU chemotherapy 4)>=4 weeks after craniotomy 5)obtained written IC (1)Neu >=2000/mm3 (2)Plt >=100000/mm3 (3)Hb >=9.0mg/dL (4)T.bil >=1.5mg/dL (5)AST, ALT =<100IU/L (6)PT-INR =<1.5 (7)Serum Cr =<1.5mg/dL (8)Proteinuria =<1+
Key exclusion criteria	1)ICH, =< 6 month after stroke 2)severe wound, ulcer, fracture 3)bleeding 4) >= 6 month after myocardiac infarction or pulmonary embolism 5)heart failure >= NYHA grade 2 6)uncontrollable hypertention 7)uncontrollable gastric ulcer 8)=< 1 year after gastrointestinal perforation 9)pregnant or conducting breastfeeding 10)already treated by Bevacizumab in the past
Target sample size	10

Research contact person
Name of lead principal investigator	Nobuhito Saito
Organization	The University of Tokyo
Division name	Department of Neurosurgery
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-5800-8853
Email	nsaito-tky@umin.net

Public contact
Name of contact person	Akitake Mukasa
Organization	The University of Tokyo Hospital
Division name	Department of Neurosurgery
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-5800-8853
Homepage URL
Email	mukasa-nsu@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Other
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	2015 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 15 Day
Anticipated trial start date	2010 Year 04 Month 15 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	2015 Year 04 Month 10 Day
Last modified on	2016 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019835