Status:
COMPLETED
Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Osseous Spine Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 improve...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00267033
Start Date
November 1 2005
End Date
August 1 2008
Last Update
December 2 2008
Active Locations (1)
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1
CHU Pitié-Salpétrière
Paris, France, 75013