UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009055 |
|---|---|
| Receipt number | R000010628 |
| Scientific Title | Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1) |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2019/04/12 12:50:06 |
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Basic information
Public title
Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Acronym
Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Scientific Title
Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Scientific Title:Acronym
Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Region
| Japan |
Condition
Condition
Brain metastases
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility of low-dose whole brain radiotherapy (25 Gy in 10 fractions) combined with stereotactic irradiation for 1-4 brain metastatic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Development rate of distant brain metastases at 6-month after treatment
Key secondary outcomes
1) Neurocognitive function at 4-month
2) Neurocognitive function at 12-month
3) Local tumor control of brain metastases
4) Overall survival
5) Cause of death
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
| Maneuver |
Interventions/Control_1
Low-dose whole brain radiotherapy (25 Gy in 10 fractions)
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) Age: 20-80 years old
2) Systemic status: KPS >= 70
3) Histopathologically confirmed
3) Indication for stereotactic irradiation (number of brain metastases, 4 or less, maximum tumor diameter, 3 cm of less)
5) Consent to neurocognitive fuctional tests and QOL questionnaire
6) Consent to this study
Key exclusion criteria
1) severe decline in neurocognitive function or language ability at baseline
2) history of brain radiation therapy
3) history of brain surgery of brain metastases
4) small cell carcinoma, germinoma, lymphoma
5) any other reasons not to fit to this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hidefumi |
| Middle name | |
| Last name | Aoyama |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Radiology
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, 9518510
TEL
025-227-2315
jrosg13-1@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidefumi |
| Middle name | |
| Last name | Aoyama |
Organization
Niigata Univerisity Graduate School of Medical and Dental Sciences
Division name
Radiology
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo-ku, 9518510
TEL
025-227-2315
Homepage URL
http://www.jrosg.jp/protocol/protocol_list.html
jrosg13-1@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University, Dept of Radiology,
Japanese Radiation Oncology Study Group
Institute
Department
Personal name
Funding Source
Organization
JSJP
Niigata University Funding for Support for Clinical Study
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Hospital
Address
1-754 Asahimachi-dori, Niigata
Tel
025-227-0730
smaru@dent.niigata-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JROSG 13-1
Org. issuing International ID_1
Japanese Radiation Oncology Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟大学医歯学総合研究科（新潟県）、県立がんセンター新潟病院（新潟県）、琉球大学附属病院（沖縄県）、埼玉県立がんセンター（埼玉県）、国立がん研究センター中央病院（東京）、熊本大学、北海道大学（北海道）、北海道がんセンター（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
http://www.jrosg.jp/protocol/file/JROSG13-1_20150630-2.pdf
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010628
