Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty. Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly, This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center : Arm A: Percutaneous vertebroplasty Arm B: External radiotherapy This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).

Detailed Description
-----------------
Bone is the most common site for metastasis. In breast and prostate cancers, 70% of patients dying of their cancer have evidence of metastatic bone disease [Coleman, 2006]. Depending on their localization, bone metastases can have debilitating consequences resulting in considerable morbidity and complex demands on health care resources. Bone spine metastases are the most frequent site observed in patients with cancer of the lung, prostate, breast and hemopoetic organs. The occurrence of spinal metastases in patients with advanced cancer can cause significant morbidity, with pain and/or neurological deficit adversely affecting the patients' quality of life. Interventional radiology takes a large place in the treatment of bone metastases. Currently, vertebroplasty appears as the most satisfactory technique for stabilization of spine metastases offering a significant improvement of the quality of life. The analgesic effect is achieved very rapidly, i.e. usually within 24 hours post-procedure. Based on several publications, around 90% of patients reported rapid pain relief following vertebroplasty with 60 to 70% of complete pain relief [Mendel, 2009]. Radiotherapy also plays a very important role in the palliative treatment of the metastatic bone. Radiotherapy is effective and well tolerated. A reduction of the pain is noticed for 70 to 80 % of the patients and begins one or two weeks after the treatment. In all, the radiotherapy increases the quality of life of the patients and can reduce the intake of analgesics [Lutz, 2011]. In a lot of cases, vertebroplasty or radiotherapy can both be performed for a same painful patient (the National Institute for Health and Clinical Excellence (NICE) approved the use of vertebroplasty for patients with spinal metastases in November 2008). Radiotherapy remains the gold-standard treatment. However, vertebroplasty could be less costly and more effective compare to radiotherapy. In fact, the superiority of vertebroplasty has been demonstrated at least in the acute post-therapeutic period with (i) more rapid autonomy recovery, (ii) reduction of antalgic intakes, and potentially less side-effects.

Official Title
-----------------
Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

Conditions
-----------------
Spine Metastases

Intervention / Treatment
-----------------
* Radiation: External radiotherapy
* Procedure: Percutaneous vertebroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years at the day of consenting to the study Patient with at least a painful spine metastasis confirmed by MRI / CT scan, Localized pain at the lesion ≥ 4 (VAS), Bone axial metastasis localised on ≤ 6 different vertebrae, Histologically established diagnosis of cancer (lung, kidney, breast, prostate, melanoma, soft tissue sarcomas) other than hematologic malignancy, myeloma, brain tumor, germ cell tumor and bone sarcomas ECOG performance status 0 to 2 (Appendix 2) Minimum life expectancy of 6 months (Tokuhashi score > 8 ) Ability to understand and willingness for follow-up visits. Covered by a medical insurance Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment Exclusion Criteria: Solitary metastasis SBRT indication Contra-indication to vertebroplasty Previous radiotherapy for pain management in the same area. Patient unable to lie prone Neurological deficit due to spinal cord compression, Active infection, Bleeding risk (platelets < 50000 and PTT > 1.5*ULN), Risk of vertebral collapse (SINS score ≥ 13), Impossible follow-up for social, geographical, familial or psychological reasons, Patient deprived of freedom, Patient enrolled in another experimental surgical trial, with therapeutic endpoint, Pregnant or breastfeeding women,Pregnant or breastfeeding women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Percutaneous vertebroplasty | Procedure: Percutaneous vertebroplasty<br> <br> * Other names: Vertebroplasty;|
| Experimental: Arm B<br>External radiotherapy | Radiation: External radiotherapy<br>* The radiation technique used for each patient will be based on local clinical practices and on number of vertebae to treat between 1*8 Gy; 5*4 Gy and 10*3 Gy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health economics evaluation | To perform a cost-utility analysis in order to provide recommendations to French decision-makers on the treatment of patients with painful spine metastases. Incremental cost-effectiveness ratio expressed in cost per quality adjusted life year (QALY) gained | 6 months after the end ot treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Budget impact analysis of vertebroplasty | Cost-assessment, Quality of life (EQ-5D) Quality adjusted life year, | 6 months after the end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health economics, Percutaneous vertebroplasty, Radiation therapy, Painful spine metastases