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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Osseous Spine Metastases

Treatments: Procedure: injection of orthopaedic cement into vertebral bodies

Study type: Interventional

Funder types: Other

Identifiers

NCT00267033

P040426

AOM04013

Details and patient eligibility

About

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

Full 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

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osseous spine metastases from squamous cell carcinoma or adenocarcinoma
• One to four painful metastases located between the second cervical vertebra and the fifth lumbar vertebra
• Moderate to severe pain
• No spinal cord compression
• Karnofsky performance status > 40

Exclusion criteria

• Previous radiotherapy or surgery
• Vertebral fracture or any other formal indication of stabilization of the rachis by surgery or vertebroplasty
• Spinal cord compression
• Known anomaly of the haemostasis, or needed anticoagulant treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 1 patient group

1

Experimental group

Description:

injection of orthopaedic cement into vertebral bodies

Treatment:

Procedure: injection of orthopaedic cement into vertebral bodies