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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 225
- 试验地点
- 13
- 主要终点
- Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Differential Cost Result Ratio (DCRR) expressed as cost per year of life earned in good health
时间窗: 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
次要结局
- 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)