Clinical Trial: Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR): a Randomized Trial

This study is not yet open for patient recruitment.
Verified by Assistance Publique - Hôpitaux de Paris October 2005

Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00267033

Purpose

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

Condition Intervention Phase
Patients With Painful Osseous Spine Metastases From a Squamous Cell Carcinoma or Adenocarcinoma of Any Tumor Site
 Procedure: Vertebroplasty:injection of orthopaedic cement into vertebral bodies
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcomes: Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 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).; Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures
Secondary Outcomes: Evaluation of pain relief one month after radiotherapy; BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.; The incidence of vertebral pathologic fracture will be registered.
Expected Total Enrollment:  186

Study start: January 2006;  Expected completion: January 2009

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00267033

Jean-Marc SIMON, MD      +33(0)-142 178 174    jean-marc.simon@psl.aphp.fr

France
      CHU Pitié-Salpétrière, Paris,  75013,  France
Jean-marc SIMON, MD  +33(0)-1 42 17 81 74    jean-marc.simon@psl.aphp.fr 
Jean-Marc SIMON, MD,  Principal Investigator

Study chairs or principal investigators

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

More Information

Publications

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.

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.

Study ID Numbers:  P040426; AOM04013
Last Updated:  December 19, 2005
Record first received:  December 19, 2005
ClinicalTrials.gov Identifier:  NCT00267033
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2006-01-10

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