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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSHF + zoledronic acid | Experimental | Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance). |
|
| RSHF | Active Comparator | Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions | Combination Product | All patients receive radiotherapy i.e. treatment on D1, D3 and D5. Several radiotherapy schemes are possible:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differential 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without vertebral compression fractures | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane SUPIOT, MD | Contact | +33240679900 | stephane.supiot@ico.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane SUPIOT, MD | ICO site SAINT HERBLAIN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut BERGONIE | Recruiting | Bordeaux | 33000 | France |
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|
| Hypo-fractured radiotherapy in stereotactic conditions | Radiation | All patients receive radiotherapy i.e. treatment on D1, D3 and D5. Several radiotherapy schemes are possible:
|
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| at inclusion, 12 and 24 months |
| Survival without bone complication | At 12 months and 24 months |
| Institut de Cancérologie de Lorraine | Recruiting | Nancy | France |
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| Hôpital Privé du Confluent | Not yet recruiting | Nantes | 44277 | France |
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| Centre de Haute Energie | Not yet recruiting | Nice | 06000 | France |
|
| Hopital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
|
| Centre Henri Becquerel | Recruiting | Rouen | 76038 | France |
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| Stéphane SUPIOT | Recruiting | Saint-Herblain | 44805 | France |
|
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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