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

Phase 3

Completed

• Conditions: Osseous Spine Metastases
• Interventions: Procedure: injection of orthopaedic cement into vertebral bodies

• Registration Number: NCT00267033
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-20
• Status Verified: 2007-03
• Primary Completion: 2008-02
• Study Completion: 2008-08
• Last Update Submitted: 2008-12-01
• Last Update Posted: 2008-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	injection of orthopaedic cement into vertebral bodies	injection of orthopaedic cement into vertebral bodies

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Pitié-Salpétrière; 🇫🇷 Paris, France