Unique ID issued by UMIN | UMIN000003564 |
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Receipt number | R000004324 |
Scientific Title | Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804) |
Date of disclosure of the study information | 2010/05/05 |
Last modified on | 2021/05/13 09:15:05 |
Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804)
Randomized controlled trial of osteoplasty
Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804)
Randomized controlled trial of osteoplasty
Japan |
Malignant bone tumor
Radiology |
Malignancy
NO
To evaluate the clinical efficacy of percutaneous osteoplasty in patients with painful malignant bone tumor comparing with drug therapy.
Efficacy
Confirmatory
Pragmatic
Phase III
Improvement of back pain
Improvement of health-related QOL/improvement of Roland-Morris Disability Questionnaire: RDQ/ toxicity profile/ survival time.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Device,equipment | Maneuver |
Percutaneous bone plasty (PBP)
Medical therapy
Not applicable |
Not applicable |
Male and Female
1. Painful bone metastases or primary bone tumors in thoracic spine, lumbar spine, or pelvic bones
2. No existing treatment for pain relief other than PBP or medical therapy
3. Palliative prognosis index less than 6.
4. Written informed consent from the patients
5. Twice measurement of health-related quality-of-life and RDQ
1. Cardiac failure requiring medical therapy
2. Extensive bone destruction in posterior aspect of vertebral bodies or compression of spinal cord by the tumor
4. Bone destruction in acetabulum
5. Uncontrollable bleeding tendency
6. History of advanced drug allergy
7. Active infectious disease
8. Active inflammatory process in intended bone
9. Under radiotherapy for the bone tumor or less than 4 weeks after the completion of RTx without progression of the symptom
10. Indication for strontium-89 radiotherapy
11. Difficulty of keeping treatment position for one hour with medical or physical treatments
12. Incapable in dose escalation of analgesics
13. Pregnancy
14. Contraindication decided by attending physician
18
1st name | Takeshi |
Middle name | |
Last name | Kobayashi |
Ishikawa Prefectural Central Hospital
Department of Diagnostic Radiology
9208530
Kanazawa-shi, Ishikawa, Japan
076-237-8211
kobaken@ipch.jp
1st name | Yasuaki |
Middle name | |
Last name | Arai |
National Cancer Center Hospital
Department of Diagnostic Radiology
1040045
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
03-3542-2511
http://jivrosg.umin.jp/
arai-y3111@mvh.biglobe.ne.jp
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Ministry of Health, Labour and Welfare
Japanese Governmental office
Japan
National Cancer Center Hospital
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
03-3542-2511
msone@ncc.go.jp
NO
愛知県がんセンター中央病院(愛知県)、旭川厚生病院(北海道)、石川県立中央病院(石川県)、岩手医科大学(岩手県)、金沢大学附属病院(石川県)、関西医科大学附属枚方病院(大阪府)、京都第一赤十字病院(京都府)、群馬大学医学部附属病院(群馬県)、神戸大学医学部附属病院(兵庫県)、国立がんセンター中央病院(東京都)、滋賀医科大学(滋賀県)、静岡県立静岡がんセンター(静岡県)、昭和大学横浜市北部病院(神奈川県)、信州大学医学部(長野県)、聖マリアンナ医科大学(神奈川県)、聖路加国際病院(東京都)、手稲渓仁会病院(北海道)、栃木県立がんセンター(栃木県)、獨協医科大学(栃木県)、奈良県立医科大学(奈良県)、福岡大学病院(福岡県)、防衛医科大学校病院(埼玉県)、三重大学医学部附属病院(三重県)、山梨大学医学部附属病院(山梨県)、琉球大学医学部(沖縄県)、国立国際医療センター戸山病院(東京都)、久留米大学病院(福岡県)
2010 | Year | 05 | Month | 05 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 06 | Month | 08 | Day |
2009 | Year | 09 | Month | 24 | Day |
2009 | Year | 11 | Month | 01 | Day |
2020 | Year | 10 | Month | 31 | Day |
2010 | Year | 05 | Month | 05 | Day |
2021 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004324
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