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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00267033

Enrollment

186

Registered

2005-12-20

Start date

2005-11-30

Completion date

2008-08-31

Last updated

2008-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osseous Spine Metastases

Keywords

Neoplasm Metastasis, Bone Neoplasms, Pain, Radiotherapy, Vertebroplasty, Combined modality therapy

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

Interventions

PROCEDUREinjection of orthopaedic cement into vertebral bodies

injection of orthopaedic cement into vertebral bodies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026