UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014455
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email s.furutani@tokushima-u.ac.jp

Public contact
1st 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
Email s.furutani@tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.