Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic V… (NCT02225223) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
Stopped: Difficulty Enrolling
United States35 participantsStarted 2014-12
Plain-language summary
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patient is ≥ 18 years old,
✓. One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
✓. Never received radiation therapy at index level(s) (following consult with radiation oncologist re: conventional treatment options) OR Received radiation therapy without adequate relief from metastatic bone pain as determined by the patient and treating physician, their treating physician would not prescribe additional radiation treatments, or refuse additional radiation therapy,
✓. Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),
✓. Woman of potential childbearing age agrees to a medically effective birth control method,
✓. Life expectancy of ≥ 2 months,
✓. Sufficient mental capacity to comply with the protocol requirements,
✓. Understands the potential risks and benefits of study participation and is willing to provide written informed consent.
Exclusion criteria
✕. Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e),
✕. Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),
✕
What they're measuring
1
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks