Spots Global Cancer Trial Database for Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)

Official Title: Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases

Study ID: NCT00267033

Conditions

Osseous Spine Metastases

Interventions

injection of orthopaedic cement into vertebral bodies

Study Description

Brief Summary: 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

Detailed Description: 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