UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010226 |
|---|---|
| Receipt number | R000011973 |
| Scientific Title | Phase 2 study of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to brain metastases using intensity modulated radiotherapy |
| Date of disclosure of the study information | 2013/03/12 |
| Last modified on | 2018/11/06 09:32:58 |
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Basic information
Public title
Phase 2 study of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to brain metastases using intensity modulated radiotherapy
Acronym
BM HA-SIB-IMRT P2
Scientific Title
Phase 2 study of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to brain metastases using intensity modulated radiotherapy
Scientific Title:Acronym
BM HA-SIB-IMRT P2
Region
| Japan |
Condition
Condition
Brain metastasis
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy and safety of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to 1-10 brain metastases using intensity modulated radiotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Intracranial progression-free survival
Key secondary outcomes
Tumor response, Local progression-free survival, Intracranial new lesion-free survival, Morbidity, Time to deterioration of neurocognitive function, Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A total dose of 30Gy is delivered in 15 fractions to whole brain, whereas 63Gy is delivered simultaneously to brain metastases. The maximum dose to bilateral hippocampus should be limited to <15Gy.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pathologically or clinically diagnosed primary malignant solid tumor
2) No history of radiotherapy for brain metastasis
3) No indication for surgical resection for brain metastasis
4) 1 to 10 brain metastases diagnosed by Gd-enhanced MRI
5) Maximum tumor diameter <3.5cm & the next largest tumor <3cm & other tumor diameters <1cm
6) KPS (karmofsky Performance Status) = or <70
7) Written informed consent
Key exclusion criteria
1) The distance of hippocampus to metastatic brain tumor < 1.5cm
2) Unknown primary site
3) Primary tumor histology of small cell lung cancer, lymphoma or other blood tumor
4) Radiologically or clinically suspected carcinomatous meningitis
5) With critical comorbidity
6) Allergy to Gd contrast medium
7) In pregnancy or with expectation of pregnancy
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Itami |
Organization
National Cancer Center Hospital, Tokyo, Japan
Division name
Division of Radiation Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
jitami@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Inaba |
Organization
National Cancer Center Hospital, Tokyo, Japan
Division name
Division of Radiation Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
koji_i_14@yahoo.co.jp
Sponsor or person
Institute
Division of Radiation Oncology and division of Neurooncology, National Cancer Center Hospital, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
国立がん研究センター中央病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011973
