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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003564
Enrollment
18
Registered
2010-05-05
Start date
2009-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant bone tumor

Interventions

Percutaneous bone plasty (PBP) Medical therapy

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Improvement of back pain

Secondary

MeasureTime frame
Improvement of health-related QOL/improvement of Roland-Morris Disability Questionnaire: RDQ/ toxicity profile/ survival time.

Countries

Japan

Contacts

Public ContactYasuaki Arai

National Cancer Center Hospital Department of Diagnostic Radiology

arai-y3111@mvh.biglobe.ne.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026