UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017100 |
|---|---|
| Receipt number | R000019835 |
| Scientific Title | Bevacizumab for recurrent or refractory malignant glioma |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2016/05/10 09:08:12 |
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Basic information
Public title
Bevacizumab for recurrent or refractory malignant glioma
Acronym
Bevacizumab for recurrent or refractory malignant glioma
Scientific Title
Bevacizumab for recurrent or refractory malignant glioma
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Nobuhito Saito |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-5800-8853
nsaito-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akitake Mukasa |
Organization
The University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-5800-8853
Homepage URL
mukasa-nsu@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019835
