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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00267033
First received: December 19, 2005
Last updated: December 1, 2008
Last verified: March 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of pain relief one month after radiotherapy [ Time Frame: one month after radiotherapy ] [ Designated as safety issue: Yes ]
  • BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • The incidence of vertebral pathologic fracture will be registered. [ Time Frame: one month after radiotherapy ] [ Designated as safety issue: No ]

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
Other Name: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Myriem CARRIER, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00267033     History of Changes
Other Study ID Numbers: P040426, AOM04013
Study First Received: December 19, 2005
Last Updated: December 1, 2008
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013