UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030056 |
|---|---|
| Receipt number | R000034320 |
| Scientific Title | A phase II trial of Decompression Surgery and Postoperative Stereotactic Body Radiotherapy for Metastatic Epidural Spinal Cord Compression |
| Date of disclosure of the study information | 2017/11/21 |
| Last modified on | 2021/07/21 00:06:49 |
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Basic information
Public title
A phase II trial of
Decompression Surgery and Postoperative Stereotactic Body Radiotherapy for Metastatic Epidural Spinal Cord Compression
Acronym
Decompression Surgery and Postoperative SBRT for MESCC
Scientific Title
A phase II trial of
Decompression Surgery and Postoperative Stereotactic Body Radiotherapy for Metastatic Epidural Spinal Cord Compression
Scientific Title:Acronym
Decompression Surgery and Postoperative SBRT for MESCC
Region
| Japan |
Condition
Condition
Metastatic Epidural Spinal Cord Compression
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of decompression surgery and postoperative stereotactic body radiotherapy for metastatic epidural spinal cord compression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control at 1 year
Key secondary outcomes
Ambulatory function, OS, local progression free survival, pattern of failure, pain response, Adverse events, QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Surgical decompression and postoperative stereotactic body radiotherapy of 24 Gy in 2 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 (including sarcoma)
2. spine metastases confirmed by images
3. Symptoms by the tumor
4. Bilsky grade is more than Ib
5. Age; 20-
6. Other lesions are controlled, or the lesion was irradiated previously
7. prognosis is expected more than 6 months
8. Written informed consent
Key exclusion criteria
1. Radiosensitive histology
2. the lesion was irradiated within 3 months
3. the lesion was treated with SBRT
4. untlerable to surgery
5. complete paralysis more than 48 hours
6. impossible to conduct decompression surgery
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Hozumi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Orthopedic surgery
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
t.hoz@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
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
Homepage URL
http://www.cick.jp/houshasenchiryou/housha_shiken/
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
| 2017 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034320
