UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017277 |
|---|---|
| Receipt number | R000020051 |
| Scientific Title | Reirradiation of Recurrent Anaplastic Ependymoma Using Radiosurgery or Fractionated Stereotactic Radiotherapy |
| Date of disclosure of the study information | 2015/04/25 |
| Last modified on | 2015/04/25 19:55:17 |
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Basic information
Public title
Reirradiation of Recurrent Anaplastic Ependymoma Using Radiosurgery or Fractionated Stereotactic Radiotherapy
Acronym
Reirradiation of recurrent ependymoma using SRS or FSRT
Scientific Title
Reirradiation of Recurrent Anaplastic Ependymoma Using Radiosurgery or Fractionated Stereotactic Radiotherapy
Scientific Title:Acronym
Reirradiation of recurrent ependymoma using SRS or FSRT
Region
| Japan |
Condition
Condition
Recurrent Anaplastic Ependymoma
Classification by specialty
| Radiology | Neurosurgery | Adult |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Recurrent ependymomas were retreated with stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) in 2 institutions. The efficacy, toxicities, and clinical differences between SRS and FSRT were analyzed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Local control rate
Key secondary outcomes
Overall survival rate, progression free survival rate and toxicities
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recurrent ependymoma patients were treated with stereotactic radiosurgery or fractionated stereotactic radiotherapy from 2007 to 2010. Patients who fulfilled the following inclusion criteria were treated and analyzed: 1) had previously undergone surgery and conventional radiotherapy as first-line treatment, 2) targets were located in or adjacent to the eloquent area of the brain, or were deep-seated, 3) the previously irradiated volume overlapped the target lesion.
Key exclusion criteria
Lesions previously treated with stereotactic radiosurgery or radiotherapy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Murai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Radiology,
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL
052-853-8274
taro8864@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Murai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Radiology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL
052-853-8274
Homepage URL
murai@syck.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients' data were retrospectively analyzed.
Management information
Registered date
| 2015 | Year | 04 | Month | 25 | Day |
Last modified on
| 2015 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020051
| 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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| Registered date | File name |
