UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021369 |
|---|---|
| Receipt number | R000024644 |
| Scientific Title | Study on safety and efficacy of the whole brain radiation 20Gy/5 time for the metastatic brain tumor |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2018/04/07 00:11:38 |
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Basic information
Public title
Study on safety and efficacy of the whole brain radiation 20Gy/5 time for the metastatic brain tumor
Acronym
Study on safety and efficacy of the whole brain radiation 20Gy/5 time
Scientific Title
Study on safety and efficacy of the whole brain radiation 20Gy/5 time for the metastatic brain tumor
Scientific Title:Acronym
Study on safety and efficacy of the whole brain radiation 20Gy/5 time
Region
| Japan |
Condition
Condition
metastatic brain tumor
Classification by specialty
| Hematology and clinical oncology | Neurology | Radiology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safe evaluation of the whole brain radiation 20Gy/5 time
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Having onset of harmful phenomenon or not
Key secondary outcomes
Reduction effect of tumor
All survival periods
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
| Other |
Interventions/Control_1
It enforces whole brain radiation at 4 Gy once a day for five days
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) The existence of the metastatic brain tumor was confirmed by CT or MRI
2) Primary tumor or having a diagnosis of an epithelial tumor (squamous cell carcinoma, adenocarcinoma) pathologically in a metastatic site
3) A vital prognosis is predicted in KPS<70 with 2-3 months
4) Age at the time of the agreement acquisition being more than 20 years old
5) An agreement being provided in a document from the patient about the trial entry
Key exclusion criteria
1) There is a history of the radiotherapy to the head
2) It was taken as the adaptation of localization radiotherapy and the surgical remedy
3) The patient whom physique maintenance is not possible, and radiotherapy cannot enforce
4) Woman with the likelihood of during the pregnancy or the pregnancy
5) The patient who judged it to be inadequate by the judgment of the examination medical attendant
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Niiya |
Organization
Showa University Hospital
Division name
Radiotherapy department
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8570
cual6_po4_4_oh_8_4h2o@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akifumi Niiya |
Organization
Showa University Hospital
Division name
Radiotherapy department
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8570
Homepage URL
cual6_po4_4_oh_8_4h2o@yahoo.co.jp
Sponsor or person
Institute
Showa University Hospital radiotherapy department
Institute
Department
Personal name
Funding Source
Organization
Showa University Hospital radiotherapy department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Urayasu Hospital radiology department
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
昭和大学病院（東京都）、順天堂大学医学部附属浦安病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 07 | 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
| 2016 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024644
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
