Unique ID issued by UMIN | UMIN000041948 |
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Receipt number | R000047314 |
Scientific Title | Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2023/04/03 12:19:59 |
Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
SIB-IM-SBRT for bone metastasis of the spine
Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
SIB-IM-SBRT for bone metastasis of the spine
Japan |
Bone metastasis of the spine
Radiology |
Malignancy
NO
To investigate efficacy and safety regarding intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine.
Safety,Efficacy
Exploratory
Phase II
1-year local control rate
Acute and late adverse events
Progression free survival
Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
The patients with spinal bone metastases will receive SIB-IM-SBRT with 30 Gy in 5 fractions.
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients with bone metastasis of the spine
2.Life expectancy of at least 1 year
3.Aged 20<= years
4.ECOG performance status 0-2
5.Written informed consent
1.Patients who had a previous RT to the treatment area
2.Dose constraints of organs at risk are not observed
3.Patients requiring radiotherapy for oncologic emergencies
4.Cases that the dose distribution can not be evaluated exactly.
5.Patients who have psychosis or psychiatric symptoms that interferes with daily life
6.Patients who are unsuitable for enrolment into the study by the investigator's judgment.
28
1st name | Takamasa |
Middle name | |
Last name | Mitsuyoshi |
Kobe City Medical Center General Hospital
Department of Radiation Oncology
650-0047
2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
078-302-4321
mitsu.t@kuhp.kyoto-u.ac.jp
1st name | Takamasa |
Middle name | |
Last name | Mitsuyoshi |
Kobe City Medical Center General Hospital
Department of Radiation Oncology
650-0047
2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
078-302-4321
mitsu.t@kuhp.kyoto-u.ac.jp
Kobe City Medical Center General Hospital
None
Local Government
Kobe City Medical Center General Hospital
2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
078-302-4321
mitsu.t@kuhp.kyoto-u.ac.jp
NO
2020 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2020 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 26 | Day |
2020 | Year | 09 | Month | 26 | Day |
2024 | Year | 09 | Month | 30 | Day |
2025 | Year | 09 | Month | 30 | Day |
2020 | Year | 09 | Month | 30 | Day |
2023 | Year | 04 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047314
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