UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010112 |
|---|---|
| Receipt number | R000011848 |
| Scientific Title | Hypofractionated stereotactic radiotherapy for large brain metastases |
| Date of disclosure of the study information | 2013/02/25 |
| Last modified on | 2021/03/08 19:19:16 |
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Basic information
Public title
Hypofractionated stereotactic radiotherapy for large brain metastases
Acronym
Hypofractionated stereotactic radiotherapy for large brain metastases
Scientific Title
Hypofractionated stereotactic radiotherapy for large brain metastases
Scientific Title:Acronym
Hypofractionated stereotactic radiotherapy for large brain metastases
Region
| Japan |
Condition
Condition
Brain metastases
Classification by specialty
| Radiology | Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and toxicity about hypofractionated stereotactic radiotherapy against large brain metastases using Cyberkife.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival rate at 6 months
Key secondary outcomes
1) Performance status and activity of daily living at 3, 6 and 12 months
2) Toxicity
3) Local control rate at 6 and 12 months
4) Occurrence of new brain metastases 6 and 12 months
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
| Device,equipment | Other |
Interventions/Control_1
Hypofractionated stereotactic radiotherapy using CyberKnife depending on the tumor volume.
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) One to four brain metastases with a maximum diameter of 2 cm or more for the largest lesion on contrast enhanced magnetic resonance imagings.
2) Unfit to craniotomy.
3) All brain metastases do not locate near the brain stem, optic nerve or chiasma.
4) Systematic status; Karnofsky Performance Status >= 70.
5) Oxygen saturation >= 96% in room air.
6) Consent to this study.
Key exclusion criteria
1) Patient with dissemination.
2) There are other malignanicies.
3) Patients in pregnancy.
4) Unknown primary cancer
5) Patient with schizoaffective disorder or other severe psychiatric disorder.
6) Patients treated with steroid for one or more months.
7) Brain metastases of malignant melanoma, sarcoma, lymphoma or small cell lung cancer.
8) Responsible doctors judged the patient inappropriate for the trial.
9) No history of craniotomy or radiotherapy to the brain
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Murai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Radiology
Zip code
467-8602
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL
052-853-8274
tmurai-ngi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Murai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Radiology
Zip code
467-8602
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL
052-853-8274
Homepage URL
taro8864@yahoo.co.jp
Sponsor or person
Institute
Department of Radiology, Nagoya City University Graduate School of Medical Sciences
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
Shin-ryoku Neurosurgery
Address
Ichizawa-cho 574-1, Asahi-ku, Yokohama
Tel
045-355-3600
cyber@syck.jp
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
横浜サイバーナイフセンター（神奈川県）、日赤医療センター（東京都）、つくばセントラル病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 25 | 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
| 2012 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011848
