2024-513248-27-00招募中3 期
Multicentre, randomized, controlled, open-label, multi-centre medicoeconomic study evaluating the efficacy of adding zoledronic acid or denosumab to Stereotaxic radiotherapy in the treatment of vertebral metastases (ZOSTER)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 10
- 主要终点
- of life gained in good health. Calculating the ICER requires : - Identifying care consumption; - Measuring costs; - Estimating overall survival; - Calculating utilities using the EQ5D-5L questionnaire (appendix 11). The ROCR will be measured at 6 months and 24 months after the start of radiotherapy.
研究概览
简要总结
to evaluate, on the basis of a cost-utility analysis and a randomised phase 3 study, the efficacy of adding zoledronic acid or denosumab to stereotactic radiotherapy in the treatment of vertebral metastases
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomisation and treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Cancer with inoperable thoracic and/or lumbar vertebral metastases
- •Age ≥ 18 years
- •Life expectancy greater than 1 year
- •WHO or PS ≤ 2
- •Effective contraception for women of childbearing age
- •Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator
- •Patient affiliated to or benefiting from the social security system
排除标准
- •Painful patient unable to maintain a supine position for 30 minutes despite analgesic treatment;
- •Patient under guardianship or unable to give consent;
- •Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
- •Previous treatment with desonumab within the last 6 months or ongoing at inclusion.
- •Patients with severe untreated hypocalcaemia.
- •Signs of neurological compression
- •Spinal cord compression or epidural involvement requiring surgery prior to radiotherapy;
- •Clinically significant hypersensitivity to zoledronic acid or denosumab, other bisphosphonates or any excipient;
- •A history of osteonecrosis of the jawbone or exposed bone or delayed healing after dental surgery;
- •Previous bisphosphonate treatment within the last 24 months or ongoing at inclusion;
- •Creatinine clearance < 30 ml/min;
- •Pregnant or breast-feeding woman;
结局指标
主要结局
of life gained in good health. Calculating the ICER requires : - Identifying care consumption; - Measuring costs; - Estimating overall survival; - Calculating utilities using the EQ5D-5L questionnaire (appendix 11). The ROCR will be measured at 6 months and 24 months after the start of radiotherapy.
of life gained in good health. Calculating the ICER requires : - Identifying care consumption; - Measuring costs; - Estimating overall survival; - Calculating utilities using the EQ5D-5L questionnaire (appendix 11). The ROCR will be measured at 6 months and 24 months after the start of radiotherapy.
次要结局
- Cost-effectiveness analysis: calculation of a Differential Cost Outcome Ratio (DCOER) expressed as a cost per life-year gained measured at 6 months and 24 months from the start of radiotherapy;
- Budget impact analysis: estimation of the target and reached populations, calculation of the additional costs and avoided costs generated by the diffusion of the innovation in the French healthcare system.
- Survival without CVF (vertebral compression fractures) estimated at 6, 12 and 24 months.
- Survival without bone complications estimated at 6, 12 and 24 months
- Acute and delayed toxicity: according to CTCAE 5 ;
- Pain control: VAS and BPI (appendix 12) assessed at inclusion, 6, 12 and 24 months;
- Local control of irradiated tumour lesions: MRI and TAP and/or PET scan (quarterly monitoring or in the event of neurological signs) assessed at 6 and 12 months;
- Neoplastic Spinal Instability Score (NSSI) assessed at inclusion, 6 and 12 months
- Assessment of bone density: bone densitometry at inclusion, 6 and 12 months;
- Measurement of markers of immune response and bone remodelling;
- Sensitivity and specificity of the algorithm for detecting the risk of fracture at 1 year.
研究者
Stéphane SUPIOT
Scientific
Institut De Cancerologie De L Ouest
研究点 (10)
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