Osseous Spine Metastases Clinical Trial
Official title:
Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown
that 8 Gy in a single fraction is very effective in providing pain relief, with complete or
partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous
vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies
through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation
provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis,
haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain
seen in 70-85% of patients. To date, no randomized trial has tested the association of
vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous
spine metastases.
A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8
Gy in a single fraction) provide enhancement pain and narcotic relief compared to
radiotherapy alone for patients with painful osseous spine metastases
Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment
arms:
- Arm 1: 8 Gy in a single fraction
- Arm 2: 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies,
within 14 days after radiotherapy
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment