Osseous Spine Metastases Clinical Trial
Official title:
Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
| Verified date | March 2007 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 186 |
| Est. completion date | August 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Pitié-Salpétrière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy. | 3 months after radiotherapy | Yes | |
| Primary | 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). | during the study | Yes | |
| Primary | Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures | during the study | Yes | |
| Secondary | Evaluation of pain relief one month after radiotherapy | one month after radiotherapy | Yes | |
| Secondary | BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life. | during the study | Yes | |
| Secondary | The incidence of vertebral pathologic fracture will be registered. | one month after radiotherapy | No |