UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014920 |
|---|---|
| Receipt number | R000017359 |
| Scientific Title | A phase II trial of hippocampus sparing in whole-brain radiotherapy in patients with multiple brain tumors: cognitive function and quality-of-life results |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2020/03/19 16:43:29 |
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Basic information
Public title
A phase II trial of hippocampus sparing in whole-brain radiotherapy in patients with multiple brain tumors: cognitive function and quality-of-life results
Acronym
hippocampus sparing in whole-brain radiotherapy for multiple brain tumors
Scientific Title
A phase II trial of hippocampus sparing in whole-brain radiotherapy in patients with multiple brain tumors: cognitive function and quality-of-life results
Scientific Title:Acronym
hippocampus sparing in whole-brain radiotherapy for multiple brain tumors
Region
| Japan |
Condition
Condition
Metastatic brain tumors and primary central nervous system lymphoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of hippocampal sparing in whole-brain radiotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function, Quality of life and over all survival
Key secondary outcomes
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 |
Interventions/Control_1
hippocampul sparing 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Metastatic brain tumors and primary central nervous system lymphoma
Key exclusion criteria
Cerebrospinal fluid dissemination
1 to 3 tumors, under 3cm diameter
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuzo |
| Middle name | |
| Last name | Hasegawa |
Organization
Chiba Cancer Center
Division name
Neurological Surgery
Zip code
260-8717
Address
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-264-5431
yhasegawa@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Yuzo |
| Middle name | |
| Last name | Hasegawa |
Organization
Chiba Cancer Center
Division name
Neurological Surgery
Zip code
260-8717
Address
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-264-5431
Homepage URL
yhasegawa@chiba-cc.jp
Sponsor or person
Institute
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba, Japan
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
non
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Cancer Center
Address
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
0432645431
ntanimura@chiba-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
千葉県がんセンター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | 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
27
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2014 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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