Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease. Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
All patients receive radiotherapy i.e. treatment on D1, D3 and D5. Several radiotherapy schemes are possible: * 20 Gy in 1 fraction; * 27 Gy in 3 fractions of 9 Gy * 30 Gy in 5 fractions of 6 Gy. All patients in the experimental arm receive an intravenous injection of at least 15 minutes of 4 mg zoledronic acid every month for 12 months. The first injection must be made no more than 3 weeks before the first day of radiotherapy. It can be performed up to J1 of radiotherapy. The injections will be carried out either at the patient's home by the nurses or in the investigator centre.
All patients receive radiotherapy i.e. treatment on D1, D3 and D5. Several radiotherapy schemes are possible: * 20 Gy in 1 fraction; * 27 Gy in 3 fractions of 9 Gy * 30 Gy in 5 fractions of 6 Gy.
Institut BERGONIE
Bordeaux, France
RECRUITINGInstitut de Cancérologie de Lorraine
Nancy, France
RECRUITINGHôpital Privé du Confluent
Nantes, France
NOT_YET_RECRUITINGCentre de Haute Energie
Nice, France
NOT_YET_RECRUITINGHopital Lyon Sud
Pierre-Bénite, France
RECRUITINGCentre Henri Becquerel
Rouen, France
RECRUITINGStéphane SUPIOT
Saint-Herblain, France
RECRUITINGDifferential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
The determination of the DCRR includes Identification of care consumption ; The measurement of costs ; overall survival at 2 years ; Calculation of utilities using the EQ5D-5L questionnaire
Time frame: 24 months
Survival without vertebral compression fractures
Time frame: At 12 months and 24 months
Pain control
Pain control will be assessed using a visual analogue scale (VAS) that measures pain intensity, prevents it, initiates or monitors drug or non-drug treatment, and the Brief Pain inventory, a questionnaire that quickly assesses the severity of pain and its impact on the patient's daily life.
Time frame: at inclusion, 12 and 24 months
Survival without bone complication
Time frame: At 12 months and 24 months
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