Unique ID issued by UMIN | UMIN000027519 |
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Receipt number | R000031543 |
Scientific Title | A Prospective trial of Decompression Surgery and Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression |
Date of disclosure of the study information | 2017/06/15 |
Last modified on | 2021/02/13 18:49:27 |
A Prospective trial of Decompression Surgery and Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
A Prospective trial of Decompression Surgery and Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Intraoperative Radiotherapy for Metastatic Epidural Spinal Cord Compression
Japan |
Metastatic Epidural Spinal Cord Compression
Radiology |
Malignancy
NO
To evaluate the efficacy and toxicity of decompression surgery and intra-operative radiotherapy for metastatic epidural spinal cord compression.
Safety,Efficacy
Exploratory
Not applicable
Ambulatory function, local control at 1 year
local control at 3 years, OS, local progression free survival, pattern of failure, pain response, Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Device,equipment |
Surgical decompression and Intra-operative radiotherapy of 20 Gy.
Adjuvant external body radiotherapy of 30 Gy in 10 fractions
20 | years-old | <= |
Not applicable |
Male and Female
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 or SINS is potentially unstable/unstable
5. Age; 20-
6. prognosis is expected more than 6 months
7. Written informed consent
1. Radiosensitive histology
2. untlerable to surgery
3. complete paralysis more than 48 hours
4. impossible to conduct decompression surgery
70
1st name | Takahiro |
Middle name | |
Last name | Hodumi |
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Orthopedic surgery
1138677
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
03-3823-2101
t.hoz@cick.jp
1st name | Kei |
Middle name | |
Last name | Ito |
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division of Radiation Oncology, Department of Radiology
1138677
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
03-3823-2101
http://www.cick.jp/houshasenchiryou/housha_shiken/
keiito@cick.jp
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
None
Self funding
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Hon-komagome 3-18-22, Bunkyo-ku
03-3823-2101
rinri@cick.jp
NO
2017 | Year | 06 | Month | 15 | Day |
Published
20
Main results already published
2017 | Year | 06 | Month | 15 | Day |
2017 | Year | 06 | Month | 15 | Day |
2017 | Year | 06 | Month | 15 | Day |
2020 | Year | 08 | Month | 01 | Day |
2017 | Year | 05 | Month | 28 | Day |
2021 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031543
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