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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00267033
First Posted: December 20, 2005
Last Update Posted: December 2, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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
Osseous Spine Metastases Procedure: injection of orthopaedic cement into vertebral bodies Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 Outcome Measures:
  • Evaluation of pain relief one month after radiotherapy [ Time Frame: 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 ]
  • The incidence of vertebral pathologic fracture will be registered. [ Time Frame: one month after radiotherapy ]

Enrollment: 186
Study Start Date: November 2005
Study Completion Date: August 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
injection of orthopaedic cement into vertebral bodies
Procedure: injection of orthopaedic cement into vertebral bodies
injection of orthopaedic cement into vertebral bodies

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267033


Locations
France
CHU Pitié-Salpétrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: jean-Marc SIMON, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Myriem CARRIER, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00267033     History of Changes
Other Study ID Numbers: P040426
AOM04013
First Submitted: December 19, 2005
First Posted: December 20, 2005
Last Update Posted: December 2, 2008
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Neoplasm Metastasis
Bone Neoplasms
Pain
Radiotherapy
Vertebroplasty
Combined modality therapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes