UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014455 |
|---|---|
| Receipt number | R000016784 |
| Scientific Title | Intensity modulated radiation therapy for multiple brain metastases |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2014/07/16 09:16:35 |
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Basic information
Public title
Intensity modulated radiation therapy for multiple brain metastases
Acronym
Intensity modulated radiation therapy for multiple brain metastases
Scientific Title
Intensity modulated radiation therapy for multiple brain metastases
Scientific Title:Acronym
Intensity modulated radiation therapy for multiple brain metastases
Region
| Japan |
Condition
Condition
Multiple brain metastases
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of whole brain radiation therapy with simultaneous integrated boost to multiple brain metastases using intensity modulated radiation therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Local control rate, Intracranial progression free survival
Key secondary outcomes
Morbidity, Neurocognitive function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Whole brain radiation therapy (30Gy in 10 fractions) is delivered with a simultaneous integrated boost of 50Gy to brain metastases.
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. MRI confirmed >= 5 brain metastases
2. Life expectancy greater than 3 months
3. Age >= 20
4. Written informed consent
5. Histologically or clinically diagnosed malignant tumor
Key exclusion criteria
1. Rapidly progressive neurological symptom
2. Small cell lung cancer
3. Pregnant or lactating women
4. Previous radiotherapy of the brain
5. MRI contraindication
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Furutani |
Organization
The University of Tokushima
Division name
Department of Radiology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7173
s.furutani@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Furutani |
Organization
The University of Tokushima
Division name
Department of Radiology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7173
Homepage URL
s.furutani@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
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
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
| 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | 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
Management information
Registered date
| 2014 | Year | 07 | Month | 02 | Day |
Last modified on
| 2014 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016784
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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