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

December 1, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • CHU Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
injection of orthopaedic cement into vertebral bodies
Procedure: injection of orthopaedic cement into vertebral bodies
injection of orthopaedic cement into vertebral bodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
Time Frame: 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).
Time Frame: during the study
during the study
Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures
Time Frame: during the study
during the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: jean-Marc SIMON, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 2, 2008

Last Update Submitted That Met QC Criteria

December 1, 2008

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040426
  • AOM04013 (french ministry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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