Unique ID issued by UMIN | UMIN000013428 |
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Receipt number | R000015572 |
Scientific Title | Feasibility study of stereotactic body radiotherapy for metastatic vertebral body tumor |
Date of disclosure of the study information | 2014/03/14 |
Last modified on | 2014/03/14 13:25:02 |
Feasibility study of stereotactic body radiotherapy for metastatic vertebral body tumor
Feasibility study of SBRT for metastatic vertebral body tumor
Feasibility study of stereotactic body radiotherapy for metastatic vertebral body tumor
Feasibility study of SBRT for metastatic vertebral body tumor
Japan |
metastatic vertebral body tumor
Radiology |
Malignancy
NO
To assess the feasibility of stereotactic body radiotherapy for metastatic vertebral body tumor in Japan.
Safety
Exploratory
Pragmatic
Phase II
Rate of Grade 3 or worse adverse effects after 6 months from treatment.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
stereotactic body radiotherapy (24 Gy/2 fractions or 24 Gy/3 fractions) for metastatic vertebral body tumor
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) ECOG PS; 0-1.
2) RPA score Group 1 or Group 2.
3) A solitary spine metastasis or two contiguous spine levels involved.
4) No previous radiation to target.
5) Lesion which is made diagnoses with MRI within 12 weeks.
6) Pathologically-confirmed cancer.
7) Patient who can keep position while treatment.
8) Patient who can understand and write informed consent in Japanese.
9) Lesion whisc is stable in SINS score.
1) Patient who cannot get MRI
2) Patient who has uncontrolled collagen disease, cardiac disease, respiratory disease or liver disorders.
3) Patient who has progressive neural symptom
4) Lesion which has cord compression grade 2 or 3.
5) Lesion which has vertebral compression fracture.
6) Patient who had chemotherapy with in 1 week before SBRT.
20
1st name | |
Middle name | |
Last name | Katsuyuki Karasawa |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division of Radiation Oncology
18-22,Honkomagome 3chome,Bunkyo-ku,Tokyo
03-3823-2101
karasawa@cick.jp
1st name | |
Middle name | |
Last name | Hiroshi Tanaka |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division of Radiation Oncology
18-22,Honkomagome 3chome,Bunkyo-ku,Tokyo
03-3823-2101
hirostan@cick.jp
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo Metropolitan Government
Local Government
NO
がん・感染症センター都立駒込病院(東京都)、埼玉医科大学国際医療センター(埼玉県)、神戸低侵襲がん医療センター(兵庫県)
2014 | Year | 03 | Month | 14 | Day |
Unpublished
Open public recruiting
2014 | Year | 03 | Month | 05 | Day |
2014 | Year | 03 | Month | 14 | Day |
2014 | Year | 03 | Month | 14 | Day |
2014 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015572
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