Clinical trial · Interventional
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma
NCT02376933CI-TRIAL-00035667terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left the department; protocol transfer did not take place.
Summary
Brief summary (as posted)
Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Vertebral Fracture | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Vertebroplasty | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vertebroplasty with Radiotherapy
- description
- Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.
- interventionNames
- Procedure: Vertebroplasty
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
- timeFrame
- 14 weeks
- description
- Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: \- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of metastatic disease to the vertebra or multiple myeloma * Negative pregnancy test within 2 weeks prior to registration * Life expectancy of \>= 3 months and Karnofsky performance status (KPS) score \>= 40 * Pain scale score \>=5 * Pain at involved vertebral body not adequately controlled * Osteolysis of vertebral bodies * Must agree to practice adequate means of birth control * Must sign informed consent prior to study entry * Must be able to understand the English language * Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule. Exclusion Criteria: * Spinal Cord Compression
References
Publications (0)
Data not yet available
No reference posted for this study.