UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054418 |
|---|---|
| Receipt number | R000061729 |
| Scientific Title | Impact of Hippocampal-Avoidance Whole-Brain Radiotherapy on Cognitive Function, Employment Status, and Quality of Life in Working-Age Populations: A Prospective Observational Study |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2025/11/17 08:25:20 |
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Basic information
Public title
Impact of Hippocampal-Avoidance Whole-Brain Radiotherapy on Cognitive Function, Employment Status, and Quality of Life in Working-Age Populations: A Prospective Observational Study
Acronym
Prospective observational study for hippocampal-avoidance whole-brain radiotherapy
Scientific Title
Impact of Hippocampal-Avoidance Whole-Brain Radiotherapy on Cognitive Function, Employment Status, and Quality of Life in Working-Age Populations: A Prospective Observational Study
Scientific Title:Acronym
Prospective observational study for hippocampal-avoidance whole-brain radiotherapy
Region
| Japan |
Condition
Condition
Brain metastases
Classification by specialty
| Pneumology | Breast surgery | Radiology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients who are expected to have a long-term prognosis and undergo hippocampal-avoidance whole-brain radiotherapy will be prospectively observed to assess intracranial recurrence, cognitive function, and change in employment status and quality of life.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intracanial progression-free survival, cognitive function at 1-year and 2-year, change in employment status at 1-year and 2-year
Key secondary outcomes
overall survival, intracranial recurrence, hippocampal recurrence, change in cognitive function every 3 months, change in employment status every 3 months, QOL, adverse events, salvage treatment
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Hippocampal-avoindance whole-brain radiotherapy is planned for multiple brain metastases
(2) No indication for surgery or stereotactic radiotherapy for brain metastases
(3) Brain metastases are confirmed by post-gadrinium enhanced T1-weighted 1-mm slice thickness MRI images
(4) Extracranial disease is controlled, and at least 5 brain metastases have been identified.
(5) No brain metastasis is identified in the hippocampus or within 5 mm of the surrounding area
(6) Primary disease is non-small cell lung cancer or non-triple negative breast cancer with a GPA score of 2.5 or more at the diagnosis of brain metastases
(7) Written informed consent for this study has been obtained.
Key exclusion criteria
(1) Leptmeningeal dissemination has been diagnosed
(2) Unable to assess cognitive function at the diagnosis of brain metastases
(3) Has a history of whole-brain radiotherapy
(4) Otherwise deemed by the physician in charge as not appropriate for registration
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yutaro |
| Middle name | |
| Last name | Koide |
Organization
Aichi Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
464-8681
Address
Kanokoden1-1, Chikusa, Nagoya, Aichi, Japan
TEL
0527626111
ykoide@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Koide |
Organization
Aichi Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
464-8681
Address
Department of Radiation Oncology
TEL
0527626111
Homepage URL
ykoide@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Aichi Cancer Center Ethics Review Committee
Address
Kanokoden1-1, Chikusa, Nagoya, Aichi, Japan
Tel
0527626111
ykoide@aichi-cc.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
| 2024 | Year | 05 | Month | 30 | 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
| 2024 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate eligibility on the date of radiotherapy request for brain metastases (date of first visit to the radiotherapy department), and for enrollment-eligible cases, the following baseline endpoints will be assessed at the time of enrollment.
1) Age
2) Sex
3) Comorbidities/pre-existing medical conditions
4) Treatment history of brain metastases
5) Histological type and subtype of primary lesion
6) Imaging findings of brain metastases
7) Prognosis of patients with brain metastases: Graded Prognose Assessment 2020 score
8) CNS symptoms and neurological findings, if present and detailed
9) Cognitive assessment: cognitive function test (MMSE) and questionnaire (FACT-Cog)
10) QOL questionnaire (EuroQOL EQ-5D-5L, EORTC QLQ-BN20)
11) Employment status questionnaire (for initial examination)
The following observation items will be evaluated at 1 month, 2 months, 3 months, and every 3 months thereafter (6,9,12,15,18,21,24 months) after whole brain radiation.
1) CNS symptoms and changes in neurological findings
2) Cognitive function assessment: MMSE, FACT-Cog
3) QOL questionnaire: EuroQOL EQ-5D-5L, EORTC QLQ-BN20
4) Working status questionnaire (for reexamination)
5) Adverse events (CTCAE version 5, ISRS brain necrosis criteria)
6) Brain metastasis imaging findings: number and size of metastases, presence and extent of edema, imaging response to treatment (RANO response assessment criteria), presence of intracranial recurrence and details if present
Management information
Registered date
| 2024 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061729
