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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014920
Receipt No. 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

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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
Email 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
Email yhasegawa@chiba-cc.jp

Sponsor
Institute 666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba, Japan
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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