Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
18 Years
N/A
Both
Osseous Spine Metastases
Trial Information
Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
Outcome Time Frame:
3 months after radiotherapy
Safety Issue:
Yes
Principal Investigator
jean-Marc SIMON, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P040426
NCT ID:
NCT00267033
Start Date:
November 2005
Completion Date:
August 2008
Related Keywords:
- Osseous Spine Metastases
- Neoplasm Metastasis
- Bone Neoplasms
- Pain
- Radiotherapy
- Vertebroplasty
- Combined modality therapy
- Neoplasm Metastasis
- Neoplasms, Second Primary
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