Clinical trial NCT00267033: Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)
Official title: Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osseous Spine Metastases
Keywords: Neoplasm Metastasis
Bone Neoplasms
Pain
Radiotherapy
Vertebroplasty
Combined modality therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-12-20
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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 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

Primary outcomes:
measure: Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
timeFrame: 3 months after radiotherapy
measure: 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).
timeFrame: during the study
measure: Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures
timeFrame: during the study
Secondary outcomes:
measure: Evaluation of pain relief one month after radiotherapy
timeFrame: one month after radiotherapy
measure: BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.
timeFrame: during the study
measure: The incidence of vertebral pathologic fracture will be registered.
timeFrame: one month after radiotherapy
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Pitié-Salpétrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: jean-Marc SIMON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/jnci/dji139.
citation: 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. doi: 10.1148/radiology.199.1.8633152.