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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Osseous Spine Metastases

Intervention / Treatment
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* Procedure: injection of orthopaedic cement into vertebral bodies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>injection of orthopaedic cement into vertebral bodies | Procedure: injection of orthopaedic cement into vertebral bodies<br>* injection of orthopaedic cement into vertebral bodies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy. |  | 3 months after radiotherapy | 
| Response will be scored as complete (no pain), partial (improvement of < 2 points in BPI), stable (+/- 1 point change in BPI) or progressive (> 2 point worsening of BPI). |  | during the study | 
| Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures |  | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain relief one month after radiotherapy |  | one month after radiotherapy | 
| BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life. |  | during the study | 
| The incidence of vertebral pathologic fracture will be registered. |  | one month after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm Metastasis, Bone Neoplasms, Pain, Radiotherapy, Vertebroplasty, Combined modality therapy