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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026856
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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