UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043319 |
|---|---|
| Receipt number | R000049455 |
| Scientific Title | Phase II trial of second course of spine stereotactic body radiotherapy |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/08/16 09:58:36 |
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Basic information
Public title
Phase II trial of second course of spine stereotactic body radiotherapy
Acronym
Phase II trial of second course of spine stereotactic body radiotherapy
Scientific Title
Phase II trial of second course of spine stereotactic body radiotherapy
Scientific Title:Acronym
Phase II trial of second course of spine stereotactic body radiotherapy
Region
| Japan |
Condition
Condition
spinal metastases
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of second stereotactic body radiotherapy for spinal metastases
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurance rate of dose limiting toxicities within 1 year after second SBRT
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
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
SBRT of 30 Gy in 5 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. pathological or clinical diagnosis of primary cancer
2. the target spine or ajdcent spine with history of SBRT
3. recurence of spine metastases confirmed by MRI
4. not radiosensitive histology
5. interval from the last SBRT more than 6 months
6. be able to keep supine position for 1 hour
7. prognosis is expected more than 6 months
8. Written informed consent
Key exclusion criteria
with severe comobidities
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Karasawa |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Division of Radiation Oncology, Department of Radiology
Zip code
1138677
Address
Hon-komagome 3-18-22, Bunkyo-ku
TEL
03-3823-2101
karasawa@cick.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Division of Radiation Oncology, Department of Radiology
Zip code
1138677
Address
Hon-komagome 3-18-22, Bunkyo-ku
TEL
03-3823-2101
Homepage URL
keiito@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
Hon-komagome 3-18-22, Bunkyo-ku
Tel
0338232101
rinri@cick.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
20
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
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049455
