UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005516 |
|---|---|
| Receipt number | R000006542 |
| Scientific Title | Single-Agent Molecularly Targeted Therapy for Adults with Recurrent Glioblastoma Multiforme: A Meta-Analysis |
| Date of disclosure of the study information | 2011/04/27 |
| Last modified on | 2011/04/27 09:44:32 |
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Basic information
Public title
Single-Agent Molecularly Targeted Therapy for Adults with Recurrent Glioblastoma Multiforme: A Meta-Analysis
Acronym
Molecularly targeted monotherapy in recurrent GBM
Scientific Title
Single-Agent Molecularly Targeted Therapy for Adults with Recurrent Glioblastoma Multiforme: A Meta-Analysis
Scientific Title:Acronym
Molecularly targeted monotherapy in recurrent GBM
Region
| Japan |
Condition
Condition
Recurrent Glioblastoma Multiforme
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To use meta-analysis to better characterize the effect of single-agent molecularly targeted therapy on overall survival (OS) in patients with recurrent or progressive GBM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
An English-language literature search of the PubMed, EMBASE, Proceedings of American Society of Clinical Oncology, Proceedings of European Society of Neuro-Oncology, Proceedings of World Federation of Neuro-Oncology, Proceedings of Society of Neuro-Oncology, and the registry of the U.S. National Institutes of Health clinicaltrials.gov databases, including all publications as of September 2010. All phase II or III trials conducted in 1995 or later were included.
Key exclusion criteria
After a review of abstracts, articles were excluded if they did not contain the relevant outcome data or if they selected patients retrospectively based on known outcomes. In the case of different publications describing the same patient cohort, only the most recent publication was used for further analysis.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mizuhiko Terasaki |
Organization
Kurume University School of Medicine
Division name
Neurosurgery
Zip code
Address
67 Asahimachi, Kurume, Fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kurume University School of Medicine
Division name
Neurosurgery
Zip code
Address
TEL
Homepage URL
jintara@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2011 | Year | 04 | Month | 27 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Relevant literature was identified using the search terms glioblastoma and the following sub-header terms: adult, clinical trial, phase II trial, phase III trial, therapy, single-agent, molecular and target. Other relevant studies were identified by manually reviewing the reference lists of already identified trials and the bibliographies of relevant books and review articles. Abstracts were downloaded for all titles of potential relevance, and full papers were obtained for all abstracts that met the following criteria 1) study population comprised of at least five patients with recurrent GBM and 2) published phase II or III trials enrolling adults with recurrent GBM
Management information
Registered date
| 2011 | Year | 04 | Month | 27 | Day |
Last modified on
| 2011 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006542
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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