Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR): a Randomized Trial - Article Caverject; Edex Kit
Clinical Trial: Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR): a Randomized Trial
This study is not yet open for patient recruitment.
Verified by Assistance Publique - Hôpitaux de Paris October 2005
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
|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 |
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Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Study start: January 2006; Expected completion: January 2009
- 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
Location and Contact Information
CHU Pitié-Salpétrière, Paris, 75013, France
Jean-Marc SIMON, MD, Principal Investigator
jean-Marc SIMON, MD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804.
Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7.
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