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Randomized controlled trial of percutaneous osteoplasty in patients with painful malignant bone tumor (JIVROSG-0804)

Phase 3
Recruiting
Conditions
Malignant bone tumor
Registration Number
JPRN-UMIN000003564
Lead Sponsor
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
18
Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement of back pain
Secondary Outcome Measures
NameTimeMethod
Improvement of health-related QOL/improvement of Roland-Morris Disability Questionnaire: RDQ/ toxicity profile/ survival time.
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