Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR) - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00267033

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 III

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases

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
1: Experimental injection of orthopaedic cement into vertebral bodies	Procedure: injection of orthopaedic cement into vertebral bodies 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:

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.

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Neoplasm Metastasis
Bone Neoplasms
Pain

Radiotherapy
Vertebroplasty
Combined modality therapy

Study placed in the following topic categories:

Bone Neoplasms
Neoplasm Metastasis
Pain

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 07, 2009