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NCT Number: NCT00267033

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

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

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Key information

Conditions

Osseous Spine Metastases Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Pitié-Salpétrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injection of orthopaedic cement into vertebral bodies

Procedure

injection of orthopaedic cement into vertebral bodies

Primary outcomes

  1. 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

  2. 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

  3. Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures

    Time frame: during the study

Secondary outcomes

  1. Evaluation of pain relief one month after radiotherapy

    Time frame: one month after radiotherapy

  2. BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.

    Time frame: during the study

  3. The incidence of vertebral pathologic fracture will be registered.

    Time frame: one month after radiotherapy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2005
Registry last updated
Dec 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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