Vertebral Metastasis
Conditions
Keywords
Hypo-fractured radiotherapy in stereotactic conditions (RSHF), zoledronic acid, medico-economic, vertebral compressive fracture
Brief summary
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.
Interventions
COMBINATION_PRODUCTZoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions
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.
RADIATIONHypo-fractured radiotherapy in stereotactic conditions
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.
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cancer with inoperable thoracic and/or lumbar vertebral metastasis; * Age ≥ 18 years old ; * Life expectancy greater than 1 year; * OMS or PS ≤ 2 ; * Effective contraception for women of childbearing age; * Patient information and free, informed and written consent, signed by the patient and investigator; * Patient affiliated or beneficiary of the social security system.
Exclusion criteria
* Cancer with inoperable thoracic and/or lumbar vertebral metastasis; * Painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment; * Patient who has received external irradiation from the proposed irradiation area \> 20 Gy ; * Signs of neurological compression; * Spinal cord compression or epidural damage requiring surgery before radiotherapy; * Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient; * History of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery; * Previous (less than 2 years) or ongoing treatment with a bisphosphonate; * Creatinine clearance \< 30 ml/min; * Pregnant or breastfeeding woman; * Patient protected or under guardianship or incapable of giving consent; * Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival without vertebral compression fractures | At 12 months and 24 months | — |
| Pain control | at inclusion, 12 and 24 months | 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. |
| Survival without bone complication | At 12 months and 24 months | — |
Countries
France
Contacts
Primary ContactStéphane SUPIOT, MD
Outcome results
None listed