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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014678
Receipt No. R000017063
Scientific Title Temozolomide plus bevacizumab for newly-diagnosed glioblastoma in the elderly over 75
Date of disclosure of the study information 2014/08/01
Last modified on 2015/05/31

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Basic information
Public title Temozolomide plus bevacizumab for newly-diagnosed glioblastoma in the elderly over 75
Acronym TMZ-BEV over 75
Scientific Title Temozolomide plus bevacizumab for newly-diagnosed glioblastoma in the elderly over 75
Scientific Title:Acronym TMZ-BEV over 75
Region
Japan

Condition
Condition glioblastoma, high-grade glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the safety and efficacy of combination therapy with temozolomide and bevacizumab for elderly patients over 75 with high-grade glioma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes safety
Key secondary outcomes overall survival, progression-free survival

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 combination therapy with temozolomide and 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

Eligibility
Age-lower limit
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histological or imaging diagnosis of high-grade glioma
2) Age more than 75
3) PS (ECOG): 0, 1, 2. PS3 by neurological deficit caused by the brain tumor is also accepted.
4) Laboratory criteria (within 2wks before registration)
Neutro more than 1,500/mm3
Hb more than 8.0 g/dL
Plt more than 100,000/mm3
AST (GOT) less than 3 folds of upper limit
ALT (GPT) less than 3 folds of upper limit
total bilirubin less than 2.0 mg/dL
serum creatinine less than 1.5 mg/dL
Key exclusion criteria 1) presence of active infection that needs systemic treatment
2) history of cranial irradiation
3) hemorrhagic diathesis, coagulation disorder (anticoagulant/antiplatelet drugs are permitted)
4) serious cardiac disorder
5) history of myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary embolism within 6 months
6) history of symptomatic intracranial hemorrhage within 6 months
7) uncured wound
8) poor control hypertension
9) serious, active peptic ulcer
10) pulmonary fibrosis or interstitial pneumonia
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hikaru Sasaki
Organization Keio University School of Medicine
Division name Neurosurgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3808
Email hsasaki@a5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Tatsuno
Organization Keio University School of Medicine
Division name Neurosurgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3808
Homepage URL
Email tatsunoy@a6.keio.jp

Sponsor
Institute Department of Neurosurgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery, Keio University School of Medicine
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 慶應義塾大学病院(東京都)
藤田保健衛生大学附属病院(愛知県)
千葉県がんセンター(千葉県)
京都大学医学部附属病院(京都府)
金沢大学附属病院(石川県)
名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2015 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017063

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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