Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vertebral Metastasis
- Sponsor
- Institut Cancerologie de l'Ouest
- Enrollment
- 225
- Locations
- 7
- Primary Endpoint
- Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
Time Frame: 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 Outcomes
- Pain control(at inclusion, 12 and 24 months)
- Survival without bone complication(At 12 months and 24 months)
- Survival without vertebral compression fractures(At 12 months and 24 months)