UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058671 |
|---|---|
| Receipt number | R000067091 |
| Scientific Title | whole brain radiotherapy for metastatic brain tumors, scalp sparing radiotherapy using IMRT: multi-insitutional study |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/01 19:08:08 |
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Basic information
Public title
whole brain radiotherapy for metastatic brain tumors, scalp sparing radiotherapy using IMRT: multi-insitutional study
Acronym
scalp sparing whole brain radiotherapy
Scientific Title
whole brain radiotherapy for metastatic brain tumors, scalp sparing radiotherapy using IMRT: multi-insitutional study
Scientific Title:Acronym
scalp sparing whole brain radiotherapy
Region
| Japan |
Condition
Condition
metastatic brain tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
CT data showed that Scalp Sparing IMRT(SS-IMRT) can deliver the required brain dose while sparing scalp hair. However, it is necessary to demonstrate that this is possible in clinical practice and that scalp hair can be preserved as calculated on the treatment planning machine. Follow-up after SS-IMRT will be similar to that in our previous prospective observational study, and the purpose of this study is to compare the results with the baseline data to demonstrate that SS-IMRT can achieve initial hair preservation while maintaining the required brain dose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The percentage of scalp hair preservation
Key secondary outcomes
The time to hair loss, time to hair regrow (median weeks)
SF-8TM standard , Skindex29 before and after SS-IMRT
Answer to the questionnaires
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Employing IMRT, reduce the dose to the scalp during whole brain radiotherapy
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
Patients with metastatic brain tumors who will undergo whole-brain radiotherapy using 3D treatment planning system at participating institutions
Patients who have provided written consent to participate in the study
Patients who are expected to survive for at least one month
Key exclusion criteria
Patients who have previously received radiation therapy to the head
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Urayasu Hospital
Division name
division of Radiation oncology departement of radiology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken
TEL
047-353-3111
anne@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Urayasu Hospital
Division name
Division of radiation oncology department of radiology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken
TEL
047-353-3111
Homepage URL
anne@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University IRB
Address
2-1-1 Hongo Bunkyoku Tokyoto
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2025 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067091
