臨床研究等提出・公開システム

Date of registration	Aug. 14, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220804

Scientific Title	A randomized, double blind, placebo controlled, multicenter Phase III trial of bevacizumab, temozolomide and radiotherapy, followed by bevacizumab and temozolomide versus placebo, temozolomide and radiotherapy followed by placebo and temozolomide in patients with newly diagnosed glioblastoma
Public Title	AVAglio

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		920
Study Type		Interventional
Study Design	Study Design	Randomized, double blind, placebo controlled, multicenter Phase III trial
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Adult patients, >=18 years of age; -Newly diagnosed glioblastoma; -WHO performance status <=2; -Stable or decreasing corticosteroid dose within 5 days prior to randomization.
	Exclusion Criteria	-Evidence of recent hemorrhage or postoperative MRI of brain; -Any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas; -Any prior radiotherapy to brain; -Clinically significant cardiovascular disease; -History of >=grade 2 hemoptysis within 1 month prior to randomization; -Previous centralized screening for MGMT status for enrollment into a clinical trial.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Glioblastoma
Intervention(s)		investigational material(s) Generic name etc : R435(Bevacizumab) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Concurrent Phase:10 mg/kg,every 2 weeks, Maintenance Phase:10 mg/kg,every 2 weeks, Monotherapy Phase:15 mg/kg,every 3 weeks control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : same as R435
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Overall survival, Progression free survival
Secondary Outcome		1-year survival rate, 2-year survival rate, QOL

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	F. Hoffmann-La Roche Ltd,

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090833
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	July. 29, 2015	Detail	Changes
9	July. 29, 2015	Detail	Changes
8	Feb. 03, 2014	Detail	Changes
7	Feb. 03, 2014	Detail	Changes
6	Oct. 01, 2012	Detail	Changes
5	Oct. 01, 2012	Detail	Changes
4	Sept. 17, 2010	Detail	Changes
3	Sept. 17, 2010	Detail	Changes
2	Aug. 14, 2009	Detail	Changes
1	Aug. 14, 2009	Detail

List of change history