UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047058 |
|---|---|
| Receipt number | R000053684 |
| Scientific Title | A single-center prospective observational study of stereotactic radiotherapy for brain metastases |
| Date of disclosure of the study information | 2022/03/02 |
| Last modified on | 2022/05/31 10:07:04 |
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Basic information
Public title
A single-center prospective observational study of stereotactic radiotherapy for brain metastases
Acronym
A single-center prospective observational study of stereotactic radiotherapy for brain metastases
Scientific Title
A single-center prospective observational study of stereotactic radiotherapy for brain metastases
Scientific Title:Acronym
A single-center prospective observational study of stereotactic radiotherapy for brain metastases
Region
| Japan |
Condition
Condition
Brain metastases
Classification by specialty
| Hematology and clinical oncology | Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment outcome of stereotactic RT in patients with brain metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of radiation necrosis
Key secondary outcomes
Overall survival, local control period
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients receive stereotactic radiotherapy for brain metastases
2) Age <= 20 years old
3) Written informed consent
Key exclusion criteria
1) Unable to receive stereotactic radiotherapy
2) Unable to obtain written informed consent
3) Inappropriate patients for this study judged by physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
takahashi.shigeo@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
takahashi.shigeo@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding necessary because this study is a single-center observational study.
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
Ethics committee, Kagawa University Faculty of Medicine
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien@kagawa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the treatment outcome of stereotactic RT in patients with brain metastases
Management information
Registered date
| 2022 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053684
