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

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

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

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:

-

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

Study chairs or principal investigators

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

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