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

NCT ID: NCT00267033

Last Updated: 2008-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-08-31

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

Conditions

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Osseous Spine Metastases

Keywords

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Neoplasm Metastasis Bone Neoplasms Pain Radiotherapy Vertebroplasty Combined modality therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

injection of orthopaedic cement into vertebral bodies

Group Type EXPERIMENTAL

injection of orthopaedic cement into vertebral bodies

Intervention Type PROCEDURE

injection of orthopaedic cement into vertebral bodies

Interventions

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injection of orthopaedic cement into vertebral bodies

injection of orthopaedic cement into vertebral bodies

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpement

Principal Investigators

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jean-Marc SIMON, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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CHU Pitié-Salpétrière

Paris, , France

Site Status

Countries

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France

References

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Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.

Reference Type BACKGROUND
PMID: 15928300 (View on PubMed)

Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7. doi: 10.1148/radiology.199.1.8633152.

Reference Type BACKGROUND
PMID: 8633152 (View on PubMed)

Other Identifiers

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AOM04013

Identifier Type: -

Identifier Source: secondary_id

P040426

Identifier Type: -

Identifier Source: org_study_id